Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)
Medical deviceClass IIOngoing
Summary: Zimmer, Inc. is recalling Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 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.
What is being recalled
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. (states named: Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas, Utah)
How to tell if yours is affected
Lot Code: Model No 815609340 ; UDI-DI (01)00887868144486(17)340904(10)66717602 ; Lot Number 66717602 Model No 815609340 ; UDI-DI (01)00887868144486(17)340904(10)66892901 ; Lot Number 66892901
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0976-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 2, 2025 |
| Reported | December 31, 2025 |
| Company | Zimmer, Inc. |
| Company location | Warsaw, IN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 24 |
More recalls from Zimmer, Inc. · all medical device recalls · recalls from December 2025