Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/catalog Number: 815509300 Software Version: N/a Product Description: Affixus 9 Mm, Length 300 M
Zimmer, Inc. is recalling Affixus Antegrade Femoral Nails (9 mm, 300 mm length, model 815509300) used in thighbone fracture surgery because some implants may have a smaller-than-intended diameter along the shaft, which could cause the implant to crack or break. If the implant fails, patients may experience tissue damage, pain, improper healing, or require additional surgery. This recall affects patients who received this specific nail implant.
- Recalling firm
- Zimmer, Inc.
- Product
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, 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
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-12-02
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4ece9c44-a1a1-40e9-830e-4f8a18232e4a