Howmedica Osteonics Corp. recalls
Every recall we track for Howmedica Osteonics Corp. — 245 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Howmedica Osteonics Corp. fell by more than half in 2025 (2, down from 28 in 2024). 1% rated “stop using now”.
All FDA recall records for Howmedica Osteonics Corp. 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 | 0 | 2 | 72 | 0 | 74 |
| 2018 | 0 | 10 | 4 | 2 | 16 |
| 2019 | 0 | 4 | 3 | 0 | 7 |
| 2020 | 1 | 1 | 15 | 0 | 17 |
| 2021 | 0 | 3 | 6 | 1 | 10 |
| 2022 | 0 | 1 | 6 | 0 | 7 |
| 2023 | 0 | 0 | 65 | 0 | 65 |
| 2024 | 1 | 5 | 19 | 3 | 28 |
| 2025 | 0 | 0 | 2 | 0 | 2 |
| 2026 (to date) | 0 | 2 | 14 | 3 | 19 |
Most common reasons for Howmedica Osteonics Corp. recalls
What to do if you have a recalled Howmedica Osteonics Corp. 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 Howmedica Osteonics Corp. recalls
48 shown- Lower riskMedical device
Howmedica Osteonics Corp. recalls TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Howmedica Osteonics recalls 605 TS Universal Baseplate Finishing Trays (Catalog 6543-6-506) sold before May 8, 2026. Residual moisture after sterilization with blue wrap may cause issues. Return or discard affected units.
Howmedica OsteonicsSep 16, 2026 - Lower riskMedical device
Howmedica Osteonics Corp. recalls AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from
Howmedica Osteonics recalls cobalt chrome elbow implants manufactured with aged polyethylene that may cause increased wear debris, requiring revision surgery. Affected units have catalog number C-M112-2-500 and UDI-DI lot P22E159.
HowmedicaJul 30, 2026 - Lower riskMedical device
Howmedica Osteonics Corp. recalls TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Howmedica recalls Triathlon Universal Baseplate Size 3 (part 5521-B-300) due to labeling errors causing confusion with Size 4 models. Affected units may have incorrect lot numbers.
HowmedicaMay 19, 2026 - Use cautionMedical device
Howmedica Osteonics Corp. recalls MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Howmedica Osteonics recalls MICS3 Angled Sagittal Saw Attachment (Part 210490) due to potential screw loosening during use that could cause detachment. All units are affected.
Howmedica OsteonicsFeb 2, 2026 - Lower riskMedical device
Howmedica Osteonics Corp. recalls The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31
Howmedica recalls Stryker CranialMask Tracker devices that cause software errors during surgery, preventing proper use. Affected units have specific part numbers and lots.
HowmedicaNov 12, 2025 - Lower riskMedical device
Howmedica Osteonics Corp. recalls 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number:
Howmedica Osteonics recalls two V40 stem implants with potential label mix-ups between model numbers 0580-1-442 and 0580-1-352, risking patient confusion.
Howmedica OsteonicsAug 28, 2025 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications
Howmedica recalls Triathlon Universal TS Baseplate Size 2 for potential improper locking with tibial inserts during knee surgery. Affected units have specific catalog and lot numbers.
HowmedicaSep 4, 2024 - UnratedMedical device
Howmedica Osteonics Corp. recalls MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Howmedica Osteonics recalls Mako Integrated Cutting System Handpieces (Catalog 209063) due to potential characterization process errors affecting constant values. Affected units have specific serial numbers listed in the recall.
Howmedica OsteonicsAug 7, 2024 - UnratedMedical device
Howmedica Osteonics Corp. recalls Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number:
Howmedica Osteonics recalls custom-made surgical device due to design mismatch with surgical proposal. Affected patients should contact for remedy.
Howmedica OsteonicsAug 5, 2024 - Lower riskMedical device
Howmedica Osteonics Corp. recalls UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number:
Howmedica recalls UNITRAX 43mm hip implant components due to potential size mismatch between packaging and actual device. Affected units include specific catalog numbers and lot numbers. Consumers should verify their product details.
HowmedicaJun 19, 2024 - Use cautionMedical device
Howmedica Osteonics Corp. recalls Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Howmedica Osteonics recalls Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 due to risk of reusing single-use sterile instruments. Affected units sold from 2006 onward.
Howmedica OsteonicsMay 23, 2024 - Lower riskMedical device
Howmedica Osteonics Corp. recalls TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog
Howmedica recalls TRIDENTII PSL Cluster58F hip implants with potential smooth acetabular shell edges. This may cause dislocation in high-risk hip patients. Affected units have specific catalog and lot numbers.
HowmedicaFeb 27, 2024 - Lower riskMedical device
Howmedica Osteonics Corp. recalls NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Howmedica recalls Triathlon TS Plus Tibia Insert (model X3 POLY 11 MM) due to potential packaging breaches that could compromise sterility. Affected units sold between 2023-2028.
HowmedicaFeb 6, 2024 - Lower riskMedical device
Howmedica Osteonics Corp. recalls HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip
Howmedica recalls HRIS ACET CUP CUT TIP 26X140 surgical instruments due to potential sterility compromise from failed seal integrity testing. Affected units include specific lot numbers and part numbers.
HowmedicaDec 22, 2023 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
Howmedica recalls older Scorpio-Flex knee implants (part 72-16-0910) due to potential oxidation in UHMWPE material that may affect performance. Affected units have lot numbers starting with 43103101.
HowmedicaDec 1, 2023 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Howmedica recalls Exeter V40 Trial Heads with catalog number 6364-8-026 that may appear green instead of blue, indicating a size 26mm, -3 head instead of 26mm, +3. Affected units sold with specific UDI-DI and lot numbers.
HowmedicaMay 3, 2023 - Lower riskMedical device
Howmedica Osteonics Corp. recalls TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Howmedica recalls TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM (Catalog #5532-G-413-E) due to mislabeling that may cause confusion with different sizes. This affects knee replacement implants.
HowmedicaApr 13, 2023 - Lower riskMedical device
Howmedica Osteonics Corp. recalls stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty
Howmedica Osteonics recalls certain Mako Restoris MCK Baseplate Trials (Size 6) due to incorrect laser marking that may affect surgical accuracy. Affected units include specific lot numbers and reference codes.
HowmedicaMar 10, 2023 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic
Howmedica recalls Full Dose CE Simplex P Single Bone Cement due to missing Turkish language instructions. All content in instructions is accurate but Turkish translation is absent.
HowmedicaNov 7, 2022 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
Howmedica recalls 10-pack bone cement with Gentamicin (P/N 6193-1-010) due to potential infection risk. Affected customers should contact Howmedica for details.
HowmedicaOct 21, 2022 - Use cautionMedical device
Howmedica Osteonics Corp. recalls Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Howmedica recalls Short Tibial Bearing MK4 (Catalog SMMLTB02) due to incompatibility with MK3 Tibial Metal Casing, requiring surgical reassembly. Affected patients should contact Howmedica for guidance.
HowmedicaAug 24, 2022 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size
Howmedica recalls Triathlon Tritanium Tibial Components (Size 6) due to potential mismatch between product size and package labeling. Affected units include specific catalog numbers and lots.
HowmedicaMar 30, 2022 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Howmedica Osteonics recalls Biolox delta Ceramic V40 Femoral Heads 32/ +4.0mm (Catalog 6570-0-232) due to potential size/offset mismatch with labeling. Affected units may have incorrect dimensions for surgical use.
Howmedica OsteonicsJan 14, 2022 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
Howmedica recalls Exeter V40 Cemented Hip (150mm) Stem (Part 0580-1-440) due to potential label mix with 125mm stem. Affected units may be used incorrectly.
HowmedicaDec 30, 2021 - Lower riskMedical device
Howmedica Osteonics Corp. recalls 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Howmedica Osteonics recalls 32MM V40 Taper Vit Head implants with potential packaging de-bonding. Affected units may have outer Tyvek lid separating from sealed package.
Howmedica OsteonicsDec 21, 2021 - Use cautionMedical device
Howmedica Osteonics Corp. recalls Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for
Howmedica Osteonics recalls Triathlon Pro Tibial Preparation Tray Revision AC- for possible wrong keel punch causing surgery delays or unintended bone damage. Affected units sold with specific catalog and lot numbers.
Howmedica OsteonicsNov 24, 2021 - Lower riskMedical device
Howmedica Osteonics Corp. recalls 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Howmedica Osteonics recalls 28MM-4 LFIT V4:10 heads with catalog number 6260-9-122 due to potential Tyvek lid debonding from sealed packaging.
Howmedica OsteonicsOct 15, 2021 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Howmedica Osteonics recalls Triathlon Prim CEM FXD BPLT 7 baseplates with potentially oversized internal profiles that may prevent proper locking of the insert. Affected units include Catalog No. 5520B700, Lot JHS2H.
Howmedica OsteonicsJul 1, 2021 - Use cautionMedical device
Howmedica Osteonics Corp. recalls Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee,
Howmedica Osteonics recalls Trial Cutting Guides for Triathlon Total Knee Systems due to potential fracture during transport or surgery, risking injury to patients.
Howmedica OsteonicsMar 5, 2021 - Use cautionMedical device
Howmedica Osteonics Corp. recalls Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Howmed: Howmedica recalls knee prostheses with Lot CTD44301 due to oversized baseplate that may prevent insert from locking. Affected units have specific model and lot number.
HowmedicaFeb 10, 2021 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI
Howmedica recalls Stryker Restoration Anatomic Hemispherical Shell Size 54 Right. The device may fall off its post in packaging, causing debris to loosen. Consumers should check product details and contact Howmedica for guidance.
HowmedicaApr 16, 2020 - Use cautionMedical device
Howmedica Osteonics Corp. recalls Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Howmedica recalls Cortoss Bone Augmentation Material (Catalogs 2101-0005 and 2101-0010) due to potential nerve damage and embolism from improper refrigeration.
HowmedicaApr 1, 2020 - Use cautionMedical device
Howmedica Osteonics Corp. recalls Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the
Howmedica recalls Stryker Omnif: Crossfire 10 Degree Series II Insert for possible missing locking wire causing surgery delays or improper implantation.
HowmedicaNov 7, 2019 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Howmedica recalls hip replacement mesh due to incorrect part mix-up in shipments. Affected units contain 4-petal mesh instead of 6-petal. No injury reported, but users should check their product.
HowmedicaOct 3, 2019 - Lower riskMedical device
Howmedica Osteonics Corp. recalls TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal
Howmedica recalls Triathlon Femoral Distal Augments with overhang issue that may protrude beyond mating component. Affected units include specific catalog numbers and lots. Contact for remedy.
HowmedicaAug 19, 2019 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number
Howmedica Osteonics recalls two types of Serrato polyaxial screws (90mm and 100mm) that were manufactured with incorrect lengths. This could lead to improper joint fixation during surgery.
Howmedica OsteonicsJun 18, 2019 - Use cautionMedical device
Howmedica Osteonics Corp. recalls Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and
Howmedica recalls Tritanium Posterior Lumbar cage implants due to reports of fractures during and after surgery. Affected models include specific lot numbers and model numbers listed in the recall notice.
HowmedicaNov 28, 2018 - UnratedMedical device
Howmedica Osteonics Corp. recalls Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means
Howmedica Osteonics recalls specific Reliance LITe Nerve Hook Bayoneted models due to potential sharp edges causing injury during nerve retraction procedures.
Howmedica OsteonicsNov 26, 2018 - Lower riskMedical device
Howmedica Osteonics Corp. recalls HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Howmedica Osteonics recalls HydroSet XT Injectable HA Bone Cement with incorrect expiry date of 17-Dec-19 instead of 11-Aug-19. Affected units have lot numbers IC02565 and ICO2570.
Howmedica OsteonicsNov 15, 2018 - Use cautionMedical device
Howmedica Osteonics Corp. recalls Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a
Howmedica recalls Tritanium TL Steerable Inserter (Cat. No. 48930000) due to locking mechanism failure that may cause implant misplacement during spinal surgery.
HowmedicaSep 12, 2018 - UnratedMedical device
Howmedica Osteonics Corp. recalls Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage:
Howmedica recalls sterile knee pins (DIA 3.2mm LNTH 89mm) due to potential outer pouch barrier compromise. Affected items were sold with lot SC22130X expiring August 2023. No remedy specified in recall.
HowmedicaSep 10, 2018 - Use cautionMedical device
Howmedica Osteonics Corp. recalls LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
Howmedica Osteonics recalls LFIT Anatomic CoCr Femoral Heads (Catalog No. 6260-9-040) manufactured before March 4, 2011, due to reports of femoral head/hip stem disassociation. Affected units include specific lots listed in the recall notice.
Howmedica OsteonicsMay 22, 2018 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use
Howmedica recalls Triathlon Revision Knee implants (Catalog #5545-A-3:301 and #5546-A-601) due to risk of receiving incorrect size implants. Affected patients should contact Howmedica for evaluation.
HowmedicaJan 30, 2018 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision
Howmedica recalls knee prosthesis devices that may contain incorrect implant sizes. This affects revision total knee arthroplasty procedures. Consumers should check product lot codes.
HowmedicaJan 12, 2018 - Lower riskMedical device
Howmedica Osteonics Corp. recalls Custom Made Implant System with Minimum Invasive Grower (MIG) component
Howmedica recalls custom implant systems made between March 2007 and October 2014 due to outdated instructions that don't clarify locking mechanism function and warnings for the locking screw. Affected users should contact the company for details.
HowmedicaDec 21, 2017 - Lower riskMedical device
Howmedica Osteonics Corp. recalls radial stem implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the
Howmedica recalls radial stem implant #3 (Sterile packed) due to higher revision rates than other proximal radial head replacements. This implant may not perform as expected post-surgery.
HowmedicaOct 24, 2017 - Use cautionMedical device
Howmedica Osteonics Corp. recalls AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow
Howmedica recalls AccuLIF TL Insertion Handle model 800804 with lot numbers 160010 and 170003 due to potential implant pivot during surgery. Affected patients should contact Howmedica for details.
HowmedicaSep 8, 2017 - Use cautionMedical device
Howmedica Osteonics Corp. recalls Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Howmedica recalls Accolade and Restoration hip implants with catalog numbers 6720-0837 and 6721-0737 due to potential contamination from unsealed sterile barriers.
HowmedicaJul 21, 2017
Howmedica Osteonics Corp. recall questions
How many recalls has Howmedica Osteonics Corp. had?
245 recalls from Howmedica Osteonics Corp. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Howmedica Osteonics Corp. recall?
Howmedica Osteonics Corp. recalls TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506., dated Sep 16, 2026. Every Howmedica Osteonics Corp. recall is listed on this page, newest first.
Why are Howmedica Osteonics Corp. products recalled?
The most common reasons on record: Potential packaging breaches of inner blister and outer sterile blister. (8); Inner and outer sterile barriers not fully sealed. (2); There is a potential for the outer Tyvek lid to de-bond from the sealed package. (2).
What should I do if I have a recalled Howmedica Osteonics Corp. 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 Howmedica Osteonics Corp. 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.