Exactech, Inc.

Complete recall history across all FDA and CPSC categories — 211 total recalls

Exactech, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (211)

FDA medical device enforcement actions by Exactech, Inc.. Showing most recent 50.

Date Product Reason Class
Feb 3, 2026 Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Cata... Impactor handle may be missing cross-pin Class II
Feb 3, 2026 Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/... Impactor handle may be missing cross-pin Class II
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm ... Due to products that have not completed design updates and performance testin... Class II
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter M... Due to products that have not completed design updates and performance testin... Class II
Sep 5, 2025 Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm ... Due to products that have not completed design updates and performance testin... Class II
Aug 15, 2025 Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG ... Reverse Shoulder humeral liners have an articular surface position outside of... Class II
Aug 15, 2025 Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 3... Reverse Shoulder humeral liners have an articular surface position outside of... Class II
Dec 31, 2024 Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G... Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II
Dec 31, 2024 Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G... Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II
Dec 31, 2024 AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G ... Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II
Apr 26, 2024 Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numb... The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were package... Class II
Apr 18, 2024 OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-2... Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyet... Class II
Apr 18, 2024 OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26M... Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyet... Class II
Apr 18, 2024 OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-... Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyet... Class II
Apr 18, 2024 OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26... Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyet... Class II
Mar 6, 2024 Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED ... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 3... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) ... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mate... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 3... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, ... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, I... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number ... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 4... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with:... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED ... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta ... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta ... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, S... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; ... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, It... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b)... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mat... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Mar 6, 2024 Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED... The packaging of these affected UHMWPE humeral liners and glenoids are noncon... Class II
Nov 21, 2023 Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03 Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II
Nov 21, 2023 Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, ... Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II
Nov 21, 2023 Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41... Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II
Nov 21, 2023 Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-00... Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II
Nov 21, 2023 Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02... Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II
Nov 21, 2023 Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-... Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II
Nov 21, 2023 Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01... Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II
Nov 21, 2023 Exactech Novation Hip System, Catalog Numbers: 134-36-45 Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II
Nov 21, 2023 Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009 Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II
Nov 21, 2023 Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, ... Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II
Nov 21, 2023 Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314... Exactech has received 3 complaints for 4 devices related to a loss of vacuum ... Class II

View all 211 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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