Exactech, Inc. recalls
Every recall we track for Exactech, Inc. — 158 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Exactech, Inc. fell by more than half in 2025 (5, down from 32 in 2024).
All FDA recall records for Exactech, 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 | 0 | 2 | 24 | 13 | 39 |
| 2018 | 0 | 0 | 3 | 1 | 4 |
| 2019 | 0 | 2 | 7 | 0 | 9 |
| 2020 | 0 | 0 | 9 | 0 | 9 |
| 2021 | 0 | 1 | 33 | 0 | 34 |
| 2022 | 0 | 0 | 10 | 0 | 10 |
| 2023 | 0 | 2 | 9 | 3 | 14 |
| 2024 | 0 | 0 | 29 | 3 | 32 |
| 2025 | 0 | 0 | 2 | 3 | 5 |
| 2026 (to date) | 0 | 0 | 1 | 1 | 2 |
Most common reasons for Exactech, Inc. recalls
What to do if you have a recalled Exactech, 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 Exactech, Inc. recalls
35 shown- Lower riskMedical device
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Exactech recalls Equinoxe Ergo Ergo Modular Impactor Handles with model 321-09-05 due to potential missing cross-pin. Affected units may require repair or replacement.
Equinoxe ErgoFeb 3, 2026 - UnratedMedical device
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software
Exactech recalls Equinoxe Ergo Adjustable Angle rTSA Reamer 46mm (model 321-59-46) due to incomplete design updates and performance testing. Products may not meet safety standards.
Equinoxe ErgoSep 5, 2025 - Lower riskMedical device
Exactech, Inc. recalls Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG
Exactech recalls specific reverse shoulder humeral liners due to articular surface position outside dimensional specifications in labeling. Affected models include 322-38-00 and 322-42-00 series with unique UDI numbers.
ExactechAug 15, 2025 - UnratedMedical device
Exactech, Inc. recalls AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM
Exactech recalls AcuMatch XLE hip implants with missing Ethylene Vinyl Alcohol (EVOH) barrier layer. These implants may not function properly during surgery. Affected models include specific sizes and item numbers listed in the recall.
ExactechDec 31, 2024 - UnratedMedical device
Exactech, Inc. recalls Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20,
Exactech recalls AcuMatch L-Series 22mm Bipolar Hip Liners produced between 2004 and August 2021 that lacked the specified EVOH layer in packaging. This could lead to improper hip joint function during surgery.
ExactechApr 26, 2024 - Lower riskMedical device
Exactech, Inc. recalls OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Exactech recalls specific OPTETRAK Inset Patella knee components due to out of specification vacuum packaging. Affected items have model numbers 200-05-23, 200-05-26, or 200-05-29. Consumers should check their product details.
ExactechApr 18, 2024 - Lower riskMedical device
Exactech, Inc. recalls Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47
Exactech recalls specific shoulder implant models due to noncompliant packaging that lacks an oxygen barrier layer, potentially affecting product integrity.
ExactechMar 6, 2024 - UnratedMedical device
Exactech, Inc. recalls AcuMatch Hip System, Catalog Number 142-32-27
Exactech recalls AcuMatch Hip System (Catalog 142-32-27) due to potential vacuum loss in inner bag. Affected units include specific serial numbers and GTIN. No remedy details provided in recall notice.
ExactechNov 21, 2023 - Use cautionMedical device
Exactech, Inc. recalls Exactech Ergo Impactor Handle, Catalog #321-09-05.
Exactech recalls Ergo Impactor Handle (Catalog #321-09-05) due to risk of ball and spring dislodging during use. Affected units include specific lot numbers and UDI-DI codes. Consumers should check their product details.
ExactechJun 5, 2023 - Lower riskMedical device
Exactech, Inc. recalls GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ
Exactech is a leading manufacturer of medical devices, including surgical instruments, implants, and other healthcare products.
ExactechAug 11, 2022 - Lower riskMedical device
Exactech, Inc. recalls OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line
Exactech is a leading medical device manufacturer specializing in orthopedic, cardiovascular, and surgical implants. Their products include joint replacements, spinal implants, and cardiovascular devices.
ExactechAug 30, 2021 - Lower riskMedical device
Exactech, Inc. recalls Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Exactech recalls specific hip prosthesis components due to incorrect labeling that could lead to improper fit. Affected units have serial numbers 6465619-6465640 and 6465642-6465648.
ExactechJun 29, 2021 - Lower riskMedical device
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX,
Exactech recalls Connexion GXL acetabular polyethylene liners for hip implants with specific catalog numbers and UDI-DI codes due to potential premature wear in certain patient configurations.
ExactechJun 29, 2021 - Use cautionMedical device
Exactech, Inc. recalls Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following
Exactech recalls HAT trials for KIT-321HAT that may have a retaining ring that disengages during use. Affected items include specific catalog numbers and lots. Consumers should check their product details.
ExactechMay 11, 2021 - Lower riskMedical device
Exactech, Inc. recalls Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Exactech recalls 11mm Equinoxe Humeral Stems with potential for incorrect Instructions for Use. Affected units include specific serial numbers and packaging lots. Consumers should contact Exactech for details.
ExactechNov 9, 2020 - Lower riskMedical device
Exactech, Inc. recalls Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Exactech recalls specific model Equinoxe Cage Glenoid implants due to potential mislabeling. Affected units include serial numbers listed in the recall notice. Consumers should verify their product against the provided list.
ExactechOct 6, 2020 - Lower riskMedical device
Exactech, Inc. recalls Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for
Exactech recalls 6.5mm Left Equinoxe Platform Fracture Stems with incorrect laser marking that could lead to improper use in spinal surgery.
ExactechSep 25, 2020 - Lower riskMedical device
Exactech, Inc. recalls Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
Exactech recalls Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm due to possible incorrect screw length. Affected units have specific serial numbers. Contact Exactech for details.
ExactechAug 24, 2020 - Lower riskMedical device
Exactech, Inc. recalls The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Exactech recalls specific Vantage Total Ankle Tibial Insert models due to incorrect size labeling on the implant. The label shows size 3 but the actual size is 4. This may cause improper fitting. No action is required as the error is not dangerous.
ExactechAug 10, 2020 - Lower riskMedical device
Exactech, Inc. recalls Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis
Exactech recalls Truliant Splined Stem Extension implants with a labeling error that shows 17mm x 80mm instead of 18mm x 120mm. This affects cemented total knee prosthesis systems.
ExactechJan 27, 2020 - Lower riskMedical device
Exactech, Inc. recalls Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe
Exactech recalls specific shoulder implants due to incorrect label translations that may cause confusion about product size. Affected units include certain right humeral stems with 10.5mm size.
ExactechDec 3, 2019 - Lower riskMedical device
Exactech, Inc. recalls 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the
Exactech recalls 2.4mm x 2.5 Fluted Pin Pouch (Catalog 351-90-22) used in ankle surgery. The pouch may contain only one pin instead of four, risking improper implantation. Affected units have specific serial numbers and packaging lots.
ExactechOct 2, 2019 - Use cautionMedical device
Exactech, Inc. recalls Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder
Exactech recalls Ergo 3.2mm K-wire for potential fracture risk during shoulder surgery. The wire may break and stay in the glenoid, causing injury. Affected units include all serial numbers with catalog number 321-52-06.
ExactechSep 10, 2019 - Use cautionMedical device
Exactech, Inc. recalls Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system
Exactech recalls Threaded Offset Cup Impactor used in hip replacements due to gritty mechanism causing difficulty turning. Affected units have specific catalog and lot numbers.
ExactechJul 24, 2019 - Lower riskMedical device
Exactech, Inc. recalls Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Exactech recalls Opteform Allograft Discs (30mm, 45mm, 90mm) due to potential cold storage equipment failure causing higher temperatures than specified. Affected units have specific catalog and serial numbers.
ExactechApr 26, 2019 - Lower riskMedical device
Exactech, Inc. recalls Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint
Exactech recalls specific Truliant Tibial Fit Trays (cemented SZ 3F/3T) due to mismatched labels. This affects certain knee replacement implants sold with serial numbers starting 5774515-5774543. No immediate action is needed as the mismatch is cosmetic and does not affect safety.
ExactechMar 13, 2019 - Lower riskMedical device
Exactech, Inc. recalls Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally
Exactech recalls Equinoxe Preserve Humeral Stem 8mm implants due to potential inclusion of Optetrak Knee System instructions instead of correct usage guide. Affected units have specific serial numbers and catalog codes.
ExactechDec 5, 2018 - Lower riskMedical device
Exactech, Inc. recalls Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Exactech recalls Equinoxe Reverse Drill Bit Kit (Catalog 321-20-00) for shoulder surgery due to incorrect drill bit configuration. Affected units have serial numbers 5214432 and 5214445.
ExactechAug 21, 2018 - Lower riskMedical device
Exactech, Inc. recalls Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Exactech recalls Tibial Alignment Guide (REF 351-10-00 Vantage Fixed Ankle) due to incorrect Global Trade Item Number (GTIN). Affected units have GTIN 10885862525629 instead of 10885862525628.
ExactechJul 13, 2018 - UnratedMedical device
Exactech, Inc. recalls Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in
Exactech recalls Optetrak Logic CC Stem Extension (22mm x 160mm) due to potentially non-conforming internal threads. Affected units sold with serial number 5370045.
ExactechMay 8, 2018 - Lower riskMedical device
Exactech, Inc. recalls Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems
Exactech recalls specific hip implants due to incorrect labeling. Affected models include Alteon HA Femoral Stem, Size 5. This may cause confusion in surgical use. Contact Exactech for details.
ExactechOct 9, 2017 - Lower riskMedical device
Exactech, Inc. recalls Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .
Exactech recalls Optetrak Constrained Condylar Offset Screw Size AA (Ref 208-04-70) due to design incompatibility with certain tibial inserts, potentially causing improper joint function.
ExactechSep 19, 2017 - Lower riskMedical device
Exactech, Inc. recalls Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally
Exactech recalls Equinoxe Shoulder System products with catalog #314-13-03 and serial numbers 5013050-501: potential mislabeling could lead to incorrect use in skeletally mature patients.
ExactechAug 31, 2017 - Use cautionMedical device
Exactech, Inc. recalls Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Exactech recalls 3.2mm Vix Bit orthopedic surgical tools due to fracture risk during use. Affected items have specific catalog and lot numbers. Consumers should contact Exactech for details.
ExactechJul 11, 2017 - Use cautionMedical device
Exactech, Inc. recalls Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to
Exactech recalls Trul:iant Tibial Trial Handle (Catalog 02-029-29-1000) due to risk of pin disassociation during surgery. Affected surgeons should contact Exactech for details.
ExactechJun 23, 2017
Exactech, Inc. recall questions
How many recalls has Exactech, Inc. had?
158 recalls from Exactech, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Exactech, Inc. recall?
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05, dated Feb 3, 2026. Every Exactech, Inc. recall is listed on this page, newest first.
Why are Exactech, Inc. products recalled?
The most common reasons on record: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. (3); Impactor handle may be missing cross-pin (2); Potentially mislabeled. (2); The product may be mislabeled. (2).
What should I do if I have a recalled Exactech, 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 Exactech, 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.