Exactech, Inc.
53 federal recalls on file, showing the 7 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Exactech, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-18FDA-DeviceClass IIStop using Exactech Equinoxe instrument kits
Exactech has recalled 596 Equinoxe Core Instrument Kits (model KIT-311X) because the impactor handle may be missing a cross-pin. This defect could affect the handle's stability during surgical use. No injuries have been reported.
- 2026-03-18FDA-DeviceClass IIStop using Exactech Equinoxe Ergo impactor handles
Exactech's Equinoxe Ergo Ergo Modular Impactor Handle (model 321-09-05) may be missing an internal cross-pin. This defect could affect the handle's stability or function during surgical use. The recall affects 120 units distributed across the US and nine other countries.
- 2025-11-26FDA-DeviceClass IIBrand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- 2025-11-26FDA-DeviceClass IIBrand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- 2025-11-26FDA-DeviceClass IIBrand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- 2025-09-24FDA-DeviceClass IIExactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
- 2025-09-24FDA-DeviceClass IIExactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
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