← FDA ENFORCEMENT
Z-0979-2026Class II

Zimmer, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Zimmer, Inc.
Product type
Device
Status
Ongoing
Report date
2025-12-31
Distribution
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Firm state
IN
Product quantity
24
Initiated by
Voluntary: Firm initiated
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.

Product description

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A

Code / lot info

Lot Code: Model No 815609400 ; UDI-DI (01)00887868144516(17)340818(10)66717605 ; Lot Number 66717605 Model No 815609400 ; UDI-DI (01)00887868144516(17)340826(10)66892904 ; Lot Number 66892904 Model No 815609400 ; UDI-DI (01)00887868144516(17)341024(10)67031552 ; Lot Number 67031552

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →