Zimmer, Inc.: Device Recall

Recall #Z-1329-2025 · 02/12/2025

Class II: Risk

Recall Details

Recall Number: Z-1329-2025
Classification: Class II
Product Type: Device
Recalling Firm: Zimmer, Inc.
Status: Ongoing
Date Initiated: 02/12/2025
Location: Warsaw, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 35 units

Reason for Recall

There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

Product Description

Z1 Femoral Hip System, Product Number 611777612

Distribution Pattern

US Nationwide distribution.

Other Recalls by Zimmer, Inc.

Class II: Risk 12/02/2025

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.
Class II: Risk 12/02/2025

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.
Class II: Risk 12/02/2025

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.
Class II: Risk 12/02/2025

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.
Class II: Risk 12/02/2025

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.

View all recalls by Zimmer, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.