Reported Dec 31, 2025 · Ongoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Brand NameAffixus Antegrade
- Femoral Nailing System Product NameAffixus Antegrade
- Femoral Nails Model/Catalog Number815509360
- Software VersionN/A
- Product Description
Affixus 9 mmLength 360 mmRight
- Trochanteric Nail ComponentN/A
- Lot codes and dates
- Lot CodeModel No 815509360 ; UDI-DI (01)00887868143540(17)340917(10)66717553 ; Lot Number 66717553 Model No 815509360 ; UDI-DI (01)00887868143540(17)340823(10)66884563 ; Lot Number 66884563
- Amount recalled
- 22
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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