Z-1649-2025 Class II Ongoing
FDA device recall Z-1649-2025 was initiated by Zimmer, Inc. on March 24, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 160 units.
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
- 160 units
Product Description
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; 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 00887868376368, All lots distributed with IFU 87-6204-051-99 Rev D or prior