FDAFDA · Food and drugs·Recall number Z-1648-2025
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
Published April 30, 2025 · Recall initiated: March 24, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
- Lot
- GTIN 00887868376351, All lots distributed with IFU 87-6204-051-99 Rev D or prior
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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