Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat Recalled by Zimmer Manufacturing B.V. Due to A product complaint was received stating that a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Manufacturing B.V. directly.
Affected Products
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
Quantity: 384 distribution events; 1 unit was returned leaving 383 units .
Why Was This Recalled?
A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3.
Where Was This Sold?
Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.
About Zimmer Manufacturing B.V.
Zimmer Manufacturing B.V. has 91 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report