FDAFDA · Food and drugs·Recall number Z-0590-2016
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.
Published January 13, 2016 · Recall initiated: December 3, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Manufacturing B.V.
- Distributor
- Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.
- Lot
- lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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