FDA-Device2025-04-30Class II
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Zimmer, Inc.
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
Affected count
215 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1646-2025Don't want to check this manually?
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