Exactech, Inc.

13 FDA enforcement actions

13 Total Recalls

0 Class I

13 Class II

0 Class III

Firm Details

Product Types: device
States: FL

All Recalls

Class II: Risk 09/05/2025 device

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Class II: Risk 09/05/2025 device

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Class II: Risk 09/05/2025 device

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Class II: Risk 08/15/2025 device

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Class II: Risk 08/15/2025 device

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Class II: Risk 12/31/2024 device

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class II: Risk 12/31/2024 device

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class II: Risk 12/31/2024 device

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class II: Risk 04/26/2024 device

The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.
Class II: Risk 04/18/2024 device

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Class II: Risk 04/18/2024 device

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Class II: Risk 04/18/2024 device

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Class II: Risk 04/18/2024 device

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.