Zimmer, Inc.: Device Recall
Recall #Z-0980-2026 · 12/02/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0980-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Zimmer, Inc.
- Status
- Ongoing
- Date Initiated
- 12/02/2025
- Location
- Warsaw, IN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23
Reason for Recall
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Product Description
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Other Recalls by Zimmer, Inc.
- Class II: Risk 12/02/2025
- Class II: Risk 12/02/2025
- Class II: Risk 12/02/2025
- Class II: Risk 12/02/2025
- Class II: Risk 12/02/2025
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.