Exactech, Inc.: Device Recall

Recall #Z-2158-2024 · 04/18/2024

Class II: Risk

Recall Details

Recall Number: Z-2158-2024
Classification: Class II
Product Type: Device
Recalling Firm: Exactech, Inc.
Status: Ongoing
Date Initiated: 04/18/2024
Location: Gainesville, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

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

Product Description

OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM

Distribution Pattern

Worldwide distribution.

Other Recalls by Exactech, Inc.

Class II: Risk 09/05/2025

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

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

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

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

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

View all recalls by Exactech, Inc. →

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.