Brand Name: Affixus Antegrade Femoral Nailing System recall
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version…
Why was Brand Name: Affixus Antegrade Femoral Nailing System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: Model No 815509340 ; UDI-DI (01)00887868143533(17)340822(10)66717552 ; Lot Number 66717552 Model No 815509340 ; UDI-DI (01)00887868143533(17)340826(10)66884562 ; Lot Number 66884562
- Product
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 22
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
- Recall date
- December 31, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)