Class IIOngoingZ-1509-2026
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Nu…
Impactor handle may be missing cross-pin
- Impactor
- Under Investigation by firm
Exactech, Inc.FLMar 18, 2026
Exactech, Inc. recalls
The FDA has posted 10 enforcement recalls from Exactech, Inc. since 2025, none of them Class I (most serious). Most recent report: Mar 18, 2026.
Class II: 10
Latest recalls
View all 10 in the recall browser →Class IIOngoingZ-1510-2026
Exactech, Inc. recalls Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number…
Impactor handle may be missing cross-pin
- Impactor
- Under Investigation by firm
Exactech, Inc.FLMar 18, 2026
Class IIOngoingZ-0536-2026
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Reverse Configuration Shoulder Prosthesis
- Release of Material/Component prior to receiving test results
Exactech, Inc.FLNov 26, 2025
Class IIOngoingZ-0537-2026
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catal…
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Reverse Configuration Shoulder Prosthesis
- Release of Material/Component prior to receiving test results
Exactech, Inc.FLNov 26, 2025
Class IIOngoingZ-0535-2026
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Reverse Configuration Shoulder Prosthesis
- Release of Material/Component prior to receiving test results
Exactech, Inc.FLNov 26, 2025
Class IIOngoingZ-2562-2025
Exactech, Inc. recalls Exactech Equinoxe
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
- Reverse Configuration Shoulder Prosthesis
- Process design
Exactech, Inc.FLSep 24, 2025
Class IIOngoingZ-2561-2025
Exactech, Inc. recalls Exactech Equinoxe
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
- Reverse Configuration Shoulder Prosthesis
- Process design
Exactech, Inc.FLSep 24, 2025
Class IIOngoingZ-1165-2025
Exactech, Inc. recalls AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-…
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
- Porous Uncemented Metal/Ceramic/Polymer + Additive Cemented Semi-Constrained Hip
- Nonconforming Material/Component
Exactech, Inc.FLFeb 19, 2025
Class IIOngoingZ-1166-2025
Exactech, Inc. recalls Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 1…
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
- Porous Uncemented Metal/Ceramic/Polymer + Additive Cemented Semi-Constrained Hip
- Nonconforming Material/Component
Exactech, Inc.FLFeb 19, 2025
Class IIOngoingZ-1167-2025
Exactech, Inc. recalls Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 1…
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
- Porous Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis
- Nonconforming Material/Component
Exactech, Inc.FLFeb 19, 2025
Firm name as filed with the FDA: “Exactech, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.