Device product
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Z-1648-2025
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 96493
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 158 units
- Official record key
device-enforcement:Z-1648-2025
Official wording
Reason: 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.
Code information: GTIN 00887868376351, All lots distributed with IFU 87-6204-051-99 Rev D or prior
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
Derived failure modes
-
Unknown
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.