Zimmer Biomet Ceramic Head recall: Labeling Error
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer…
Why was Zimmer Biomet Ceramic Head recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00887868376320, All lots distributed with IFU 87-6204-051-99 Rev D or prior
- Product
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 416 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
- Recall date
- April 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)