Zimmer, Inc.: Device Recall

Recall Details

Recall Number

Z-1647-2025

Classification

Class II

Product Type

Device

Recalling Firm

Zimmer, Inc.

Status

Ongoing

Date Initiated

03/24/2025

Location

Warsaw, IN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

167 units

Reason for Recall

The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

Product Description

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.

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. →