Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A
- Company
- Zimmer Inc.
- Recall Initiated
- December 2, 2025
- Posted
- December 22, 2025
- Recall Number
- Z-0972-2026
- Quantity
- 22
- Firm Location
- Warsaw, IN
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.
Distribution
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Lot / Code Info
Lot Code: Model No 815509420 ; UDI-DI (01)00887868143571(17)340920(10)66717556 ; Lot Number 66717556 Model No 815509420 ; UDI-DI (01)00887868143571(17)340920(10)66884566 ; Lot Number 66884566
Root Cause
Process design
Action Taken
Firm began notifying customers on December 2, 2025 via Urgent Medical Device Recall letters. Distributors are to locate and quarantine affected product in their inventory. They must also return all affected product from their distributorship and from affected hospitals within their territory. Risk Managers are to assist Zimmer Biomet sales representatives in quarantining all affected product. Sales representatives will remove the product from customer facilities. Surgeons are to maintain awareness of the issue, but there are no patient-monitoring instructions related to this recall recommended beyond their existing follow-up schedules.