Brand Name: Affixus Antegrade Femoral Nailing System Prod... (Zimmer, Inc.) – affected implants may have undersized... (2025)
This product may cause serious physical injury.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A
Brand
Zimmer, Inc.
Lot Codes / Batch Numbers
Lot Code: Model No 815509320, UDI-DI (01)00887868143526(17)340820(10)66717551, Lot Number 66717551 Model No 815509320, UDI-DI (01)00887868143526(17)340821(10)66884561, Lot Number 66884561
Products Sold
Lot Code: Model No 815509320 ; UDI-DI (01)00887868143526(17)340820(10)66717551 ; Lot Number 66717551 Model No 815509320 ; UDI-DI (01)00887868143526(17)340821(10)66884561; Lot Number 66884561
Zimmer, Inc. is recalling Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M due to Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.