Zimmer, Inc. recalls Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femor
- Recalling company
- Zimmer, Inc.
- Product
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 2, 2025
- Reported
- Dec 31, 2025
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
- Status
- Ongoing
- Quantity
- 24
- Lot / codes
- Lot Code: Model No 815609440 ; UDI-DI (01)00887868144530(17)340819(10)66717607; Lot Number 66717607 Model No 815609440 ; UDI-DI (01)00887868144530(17)341025(10)67031553 ; Lot Number 67031553
- Company location
- Warsaw, IN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0981-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0981-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.