Z-1645-2025 Class II Ongoing

Recalled by Zimmer, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
April 30, 2025
Initiation Date
March 24, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
416 units

Product Description

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented

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.

Distribution Pattern

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

Code Information

GTIN 00887868376320, All lots distributed with IFU 87-6204-051-99 Rev D or prior