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Zimmer Manufacturing B.V. recalls NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Componen
Recalled January 13, 2016 · FDA recall Z-0590-2016 · Zimmer Manufacturing B.V
Hazard
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. · FDA Class II
Units
384 distribution events; 1 unit was returned leaving 383 units .
Sold at
Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.
Description
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.
Product
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.
Manufacturer(s)
Zimmer Manufacturing B.V.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →