Smith & Nephew, Inc. recalls
Every recall we track for Smith & Nephew, Inc. — 136 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Smith & Nephew, Inc. fell by more than half in 2025 (2, down from 11 in 2024). 1% rated “stop using now”.
All FDA recall records for Smith & Nephew, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 1 | 1 | 7 | 1 | 10 |
| 2018 | 0 | 3 | 15 | 2 | 20 |
| 2019 | 0 | 2 | 6 | 0 | 8 |
| 2020 | 0 | 11 | 47 | 4 | 62 |
| 2021 | 0 | 0 | 9 | 0 | 9 |
| 2022 | 0 | 0 | 3 | 0 | 3 |
| 2023 | 0 | 0 | 9 | 1 | 10 |
| 2024 | 0 | 1 | 9 | 1 | 11 |
| 2025 | 0 | 0 | 2 | 0 | 2 |
| 2026 (to date) | 0 | 1 | 0 | 0 | 1 |
Most common reasons for Smith & Nephew, Inc. recalls
What to do if you have a recalled Smith & Nephew, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Smith & Nephew, Inc. recalls
60 shown- Use cautionMedical device
Smith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Smith & Nephew recalls TRIGEN Proximal Straight Humeral Nail 8/7 X 16 with missing distal holes that may require revision surgery. Affected units have specific lot numbers and UDI-DI codes.
Smith & NephewMar 16, 2026 - Lower riskMedical device
Smith & Nephew, Inc. recalls BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Smith & Nephew recalls BIOSURE HA screws with labeling errors. Affected screws may be misidentified, leading to improper use in hip replacements. Contact for details.
Smith & Neph: Inc.Nov 24, 2025 - Lower riskMedical device
Smith & Nephew, Inc. recalls META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Smith & Nephew recalls specific lag/compression screw kits where the compression screw may be undersized, causing non-functionality. Affected kits require replacement, which can take over 30 minutes.
Smith & NephewMar 18, 2025 - Use cautionMedical device
Smith & Nephew Inc. recalls BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Smith & Nephew recalls BIORAPTOR suture anchors due to packaging design flaws that could breach sterile barriers. Affected units include specific part numbers and batch dates. Consumers should contact the company for details.
Smith & NephewOct 29, 2024 - Lower riskMedical device
Smith & Nephew, Inc. recalls Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile,
Smith & Nephew recalls Tandem Bipolar Hip System components with oversized retainer rings that could cause improper joint alignment during surgery. Affected units include specific model and batch numbers.
Smith & NephewOct 15, 2024 - Lower riskMedical device
Smith & Nephew Inc recalls smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275;
Smith & Nephew recalls a specific knee implant model that was shipped with the wrong component. This could lead to improper fitting and potential complications during surgery.
Smith & NephewOct 2, 2024 - Lower riskMedical device
Smith & Nephew Inc recalls smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE,
Smith & Nephew recalls a specific knee implant model that was shipped with the wrong size (size 4 left) instead of size 3 left. This could lead to improper fitting and complications during surgery.
Smith & NephewOct 2, 2024 - Lower riskMedical device
Smith & Nephew Inc. recalls ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues.
Smith & Nephew recalls certain Rotation Medical Tendon Staples due to potential improper packaging seals that could compromise sterility. Affected units include specific batch numbers for prosthetic tissue fixation.
Smith & NephewAug 12, 2024 - Lower riskMedical device
Smith & Nephew, Inc. recalls DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
Smith & Nephew recalls Diamond Point K-Wire fasteners due to packaging error causing wrong size wires to be shipped. Affected units may cause improper bone fixation if used.
Smith & NephewJul 9, 2024 - Lower riskMedical device
Smith & Nephew Inc recalls smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF
Smith & Nephew recalls specific femoral head implants due to incorrect size packaging. This may lead to improper fit during surgery. Affected units include REF 71343204 (32mm) and REF 71343604 (36mm) with batch numbers.
Smith & NephewApr 24, 2024 - Lower riskMedical device
Smith & Nephew, Inc. recalls JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
Smith & Nephew recalls specific knee prostheses due to mislabeling that could lead to incorrect use. Affected models include JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262. Contact for details.
Smith & NephewSep 27, 2023 - Lower riskMedical device
Smith & Nephew Inc recalls smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee
Smith & Nephew recalls a specific knee implant model due to being shipped with the wrong size. This could lead to improper fit and potential complications during surgery.
Smith & NephewAug 31, 2023 - Lower riskMedical device
Smith & Nephew, Inc. recalls TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Smith & Nephew recalls a specific femur nail model due to being shipped with the wrong length. This could lead to improper surgical use. Consumers should check their product labels and contact the company for details.
Smith & NephewJul 24, 2023 - Lower riskMedical device
Smith & Nephew, Inc. recalls Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b)
Smith & Nephew recalls ENGAGE Cementless Partial Knee Systems with potential higher revision rates than similar devices. Affected models include REF 1-10011-100 to 300. No immediate action needed but monitor for complications.
Smith & NephewMay 2, 2023 - Lower riskMedical device
Smith & Nephew, Inc. recalls JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Smith & Nephew recalls JOURNEY II Tibia Insert Medial Size 7-8 8MM due to mispackaging. The box contains the wrong size (1-2 12MM) instead of the correct size. Consumers should check product details to determine if affected.
Smith & Neph: A short, human brand name for headings (e.g.Mar 27, 2023 - Lower riskMedical device
Smith & Nephew, Inc. recalls (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate
Smith & Nephew recalls two Genesis II Non-Porous Tibial Baseplates (Size 5 Right and Size 4 Left) due to mispackaging. The inner tray matches the inner tray but does not match the outer box label and chart sticks.
Smith & NephewJun 27, 2022 - Lower riskMedical device
Smith & Nephew Inc recalls LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Smith & Nephew recalls two surgical products due to mislabeling in shipments. Affected items may be confused with different models, but no safety hazard is reported.
Smith & NephewApr 19, 2022 - Lower riskMedical device
Smith & Nephew, Inc. recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Smith & Nephew recalls INTEGRA SURFIX ALPHA Torx 10 screwdrivers that may not properly engage with Surfix Alpha Lock screws, causing potential assembly issues.
Smith & NephewJan 4, 2022 - Lower riskMedical device
Smith & Nephew, Inc. recalls Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during
Smith & Nephew recalls Acufex Access Advanced Positioning Kit due to improper sterilization. Products shipped to Global Distribution Center instead of sterilizer, risking infection. Affected units have specific product numbers and lot numbers.
Smith & Neph: Inc.Dec 14, 2021 - Lower riskMedical device
Smith & Nephew, Inc. recalls smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Smith & Nephew recalls specific femur plates due to erroneous MRI scanning data in instructions, potentially affecting surgical safety. Affected models include REF 72573101 with batch numbers 20HM10249-20HM10251 and 20HM22783.
Smith & NephewNov 1, 2021 - Lower riskMedical device
Smith & Nephew, Inc. recalls Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X
Smith & Nephew recalls two sterile screw models due to switched labels on packages. This could lead to using the wrong screw size in medical procedures. Affected units have specific batch numbers.
Smith & NephewOct 25, 2021 - Lower riskMedical device
Smith & Nephew, Inc. recalls 6.5MMX165MM CANNULATED SCREW
Smith & Nephew recalls 6.5MMX165MM cannulated screws due to incorrect threading label. Affected models may have partial threading instead of full threading.
Smith & Neph: Inc.Sep 20, 2021 - Lower riskMedical device
Smith & Nephew, Inc. recalls LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P
Smith & Nephew recalls specific knee implant components due to surface damage from manufacturing. Affected units have a unique reference number and size. Consumers should contact the manufacturer for details.
Smith & NephewMay 19, 2021 - Lower riskMedical device
Smith & Nephew, Inc. recalls CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of
Smith & Neph: Recall of 6mm x 30mm interference screws due to mislabeled box containing 6mm x 20mm screws. Affected users should check product details.
Smith & NephewApr 8, 2021 - Lower riskMedical device
Smith & Nephew, Inc. recalls VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage:
Smith & Nephew recalls VERSABOND AB 40 GRAMS bone cement (Product #71271440) due to potential heat/humidity exposure causing sandy texture. Affected units may have grainy consistency when mixing.
Smith & NephewDec 18, 2020 - Lower riskMedical device
Smith & Nephew, Inc. recalls Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft
Smith & Nephew recalls bone fixation nails (TRIGEN INTERTAN) with model numbers 71675535 and 71675532 due to manufacturing packaging error. Affected units may have incorrect labeling.
Smith & Neph: Inc.Nov 2, 2020 - Lower riskMedical device
Smith & Nephew, Inc. recalls Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior
Smith & Nephew recalls Genesis (GII) surgical devices due to a design flaw in the anterior locking detail that may not meet specifications. Affected models include 71420966 with lot 18JY09702.
Smith & Neph: Inc.Sep 21, 2020 - Lower riskMedical device
Smith & Nephew, Inc. recalls 5.5MM Arthrogarde Hip Access Cannula
Smith & Nephew recalls 5.5MM Arthrogarde Hip Access Cannulas with faulty J Lock that may not lock correctly into irrigation extenders or arthroscopes during surgery.
Smith & Neph: Inc.Sep 21, 2020 - Use cautionMedical device
Smith & Nephew, Inc. recalls OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
Smith & Nephew recalls OSTEORAPTOR 2.3W absorbable suture anchors with batch numbers 2012768-2056307 due to potential pouch seal failure causing sterile contamination during surgery.
Smith & NephewSep 9, 2020 - Lower riskMedical device
Smith & Nephew, Inc. recalls EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis,
Smith & Nephew recalls EVOS Screws with incorrect expiration dates on labels. These screws are used in bone repair procedures. Affected parts include specific model numbers and batch lots.
Smith & NephewAug 24, 2020 - Use cautionMedical device
Smith & Nephew, Inc. recalls Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the
Smith & Nephew recalls Single RIKKI retractors with specific lot numbers due to improper heat treatment. These surgical tools may fail during use, risking injury to patients or staff.
Smith & NephewAug 3, 2020 - Lower riskMedical device
Smith & Nephew, Inc. recalls Tibial knee prosthesis
Smith & Nephew recalls specific lots of Tibial knee prosthesis models due to potential internal material defects that could affect safety. Affected units include model numbers 71420164, 71420166, 71420184 and listed lot numbers.
Smith & NephewJul 16, 2020 - Lower riskMedical device
Smith & Nephew, Inc. recalls PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients,
Smith & Nephew recalls PeriLoc Targeter 4.5mm Distal Femur handles marked as left but intended for right hand use. This could lead to incorrect surgical application. Affected units have specific product numbers and lot numbers.
Smith & NephewJun 29, 2020 - Use cautionMedical device
Smith & Nephew, Inc. recalls Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical
Smith & Nephew recalls surgical drill packs with one sleeve instead of two, risking improper bone tunnel drilling during rotator cuff repairs. Affected units include specific lot numbers from August 2023.
Smith & NephewJun 24, 2020 - Lower riskMedical device
Smith & Nephew, Inc. recalls SUTUREFIX ULTRA Suture, Product number 72203855
Smith & Nephew recalls SUTUREFIX ULTRA Suture (product 72203855) due to packaging error sending XL drill instead of S drill. This longer drill may cause injury during use.
Smith & NephewJun 24, 2020 - UnratedMedical device
Smith & Nephew, Inc. recalls TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides
Smith & Nephew recalls TRIGEN intramedullary nails with a manufacturing error causing improper re-sterilization of the UHMWPE sleeve. Affected models include 71655139 lot 19BM13592A.
Smith & NephewJun 24, 2020 - UnratedMedical device
Smith & Nephew, Inc. recalls smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size
Smith & Nephew recalls R3 acetabular shells with out-of-specification manufacturing due to a production error. Affected sizes and lots listed in the recall notice.
Smith & NephewApr 22, 2020 - Lower riskMedical device
Smith & Nephew, Inc. recalls Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Smith & Nephew recalls 5.5mm FOOTPRINT Ultra PK Suture Anchors with specific part numbers due to potential displacement of the anchor tip protector, risking sterile breaches during medical procedures.
Smith & NephewMar 17, 2020 - Use cautionMedical device
Smith & Nephew, Inc. recalls NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed
Smith & Nephew recalls NAVIO Soft Tissue Protectors in specific instrument kits due to potential bone pin sticking during surgery. Affected kits have listed lot numbers; contact for remedy.
Smith & NephewFeb 27, 2020 - Use cautionMedical device
Smith & Nephew, Inc. recalls JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep
Smith & Nephew recalls JOURNEY II Uni Resection Prep Trial surgical instruments with a spike rail that may disassemble due to an oversized thru-hole. Affected models include sizes 1-10 with specific lot codes.
Smith & NephewJan 28, 2020 - Lower riskMedical device
Smith & Nephew, Inc. recalls TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft
Smith & Nephew recalls TwinFix Ti 2.8 mm HS Suture Anchor due to potential sterile barrier breach from protective tube dislodging, risking device contamination.
Smith & NephewDec 30, 2019 - Lower riskMedical device
Smith & Nephew, Inc. recalls LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Smith & Nephew recalls Legion PS High Flex XLPE size 5-6 9mm Articular Insert due to incorrect part packaging. Affected units may have improper components.
Smith & NephewDec 19, 2019 - Lower riskMedical device
Smith & Nephew, Inc. recalls LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block
Smith & Nephew recalls certain LEGION AP Cutting Blocks with oversize green plunger holes that may not meet design specs. Affected units include sizes 4, 6, 7, and 8 with specific lot numbers.
Smith & NephewDec 16, 2019 - Use cautionMedical device
Smith & Nephew, Inc. recalls smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical
Smith & Nephew recalls PROFIX Mallet surgical instruments with potential for poly tip to become loose during knee or hip surgery, risking particles entering the surgical field or delays.
Smith & NephewNov 11, 2019 - Lower riskMedical device
Smith & Nephew, Inc. recalls LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures
Smith & Nephew recalls LAG screw 3.2mm guide pin sleeves (ref 71674032) due to manufacturing error causing detent balls to not fully compress. Affected batch numbers include 18DM11613A, 18HM02575, 18HM13327A, 18HM20956A.
Smith & NephewOct 7, 2019 - Lower riskMedical device
Smith & Nephew, Inc. recalls smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
Smith & Nephew recalls specific stem sizes due to incorrect label indicating size 1 instead of -1. This may cause confusion in medical use. Affected items have unique reference numbers.
Smith & NephewFeb 19, 2019 - Use cautionMedical device
Smith & Nephew, Inc. recalls SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
Smith & Nephew recalls SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM (S&N 75004613) due to pin disassembly risk. Affected units have specific lot numbers.
Smith & NephewJan 7, 2019 - Use cautionMedical device
Smith & Nephew, Inc. recalls JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a
Smith & Nephew recalls certain Journey II XR Tibial Posterior Keel Punches due to higher than expected bone fracture risk during use. Affected units have specific batch numbers. Consumers should contact the company for details.
Smith & NephewDec 10, 2018 - Use cautionMedical device
Smith & Nephew, Inc. recalls Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral
Smith & Nephew recalls a specific lot of Legion AP femoral cutting blocks due to an oversized spring that could cause injury during surgery.
Smith & NephewSep 18, 2018 - Lower riskMedical device
Smith & Nephew, Inc. recalls JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116,
Smith & Nephew recalls specific knee inserts due to higher revision rates than typical in joint replacement registries. Affected models include 74023111-74023488 and 74203326. No immediate action needed but check if your insert is listed.
Smith & NephewJun 13, 2018 - Lower riskMedical device
Smith & Nephew, Inc. recalls Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c)
Smith & Nephew recalls specific hip cup models in the US that lack required FDA labeling, potentially causing confusion during use. Affected units include sizes 54-64mm with certain reference numbers and lots.
Smith & NephewMay 11, 2018 - Lower riskMedical device
Smith & Nephew, Inc. recalls smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Smith & Nephew recalls Genesis II 13mm tibial punches with a 2mm size error that may cause improper fit during surgery. Affected units have specific reference number 71440408.
Smith & NephewMay 4, 2018 - UnratedMedical device
Smith & Nephew, Inc. recalls smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
Smith & Nephew recalls hip prostheses with undersized taper length that could cause improper fit during surgery. Affected models include Anthology Porous High Offset Stem, 7H size, 32mm x 112mm, lot numbers 17LM22019, 17LM10934, 17LM05900.
Smith & NephewMay 2, 2018 - Lower riskMedical device
Smith & Nephew, Inc. recalls smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System
Smith & Nephew recalls Genesis II knee bushings with a laser marking error that could cause incorrect implant placement. Affected units have a specific lot number and require verification.
Smith & NephewApr 9, 2018 - Lower riskMedical device
Smith & Nephew, Inc. recalls smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients
Smith & Nephew recalls specific articular inserts due to improper packaging that may cause injury during surgery. Affected products include batch numbers 11DM11664 and 15BM09445.
Smith & NephewMar 30, 2018 - Lower riskMedical device
Smith & Nephew, Inc. recalls D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD
Smith & Neph: D-RAD Self-Tapping Locking Screws (Lot 17GM04522) may have over-tolerance threads causing improper fracture fixation. Affected patients should contact manufacturer for details.
Smith & NephewMar 7, 2018 - Lower riskMedical device
Smith & Nephew, Inc. recalls smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision
Smith & Nephew recalls Legion HK Femoral Wedge (Wedge and Screw) 5mm size due to screws being 5mm instead of 10mm, which can't be used with the device. Affected items have batch number 14AAP6352A.
Smith & NephewFeb 1, 2018 - Lower riskMedical device
Smith & Nephew, Inc. recalls LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee
Smith & Nephew recalls Legion Hemi Step Tibial Wedge RK/HK implants due to incorrect screw packaging. This affects constrained knee surgery patients. Contact for replacement.
Smith & NephewJan 15, 2018 - Lower riskMedical device
Smith & Nephew, Inc. recalls Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application
Smith & Nephew recalls software version 5.2.5/5.2.6 for rare inverted frame previews during surgical planning, potentially causing misalignment in bone fixation procedures.
Smith & NephewDec 13, 2017 - Lower riskMedical device
Smith & Nephew, Inc. recalls Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Smith & Nephew recalls specific sutures due to packaging that may allow sterile barrier breaches. Affected batches include 7211015 with batch numbers 50498479-50603355. Stop using if you have these items.
Smith & NephewDec 11, 2017
Smith & Nephew, Inc. recall questions
How many recalls has Smith & Nephew, Inc. had?
136 recalls from Smith & Nephew, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Smith & Nephew, Inc. recall?
Smith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816, dated Mar 16, 2026. Every Smith & Nephew, Inc. recall is listed on this page, newest first.
Why are Smith & Nephew, Inc. products recalled?
The most common reasons on record: A manufacturing error resulted in out of specification R3 Acetabular Shells (6).
What should I do if I have a recalled Smith & Nephew, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Smith & Nephew, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.