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.
Check against the official notice below — it lists the full affected range.
Zimmer Manufacturing B.V. is recalling two lots of tibial components used in knee replacement surgery due to a labeling and packaging error. A complaint indicated that a carton labeled as containing a Precoat Stemmed Tibia Size 3 component actually contained a non-augmented Stemmed Tibia Plate Size 3 instead. The affected products are lot 62491580 (Part Number 00598003701) and lot 62460315 (Part Number 00598603701), which were distributed worldwide to 13 countries including Germany, Belgium, France, the UK, Sweden, and Thailand, affecting 384 distribution events with 383 units remaining in circulation.
The record does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand. Quantity: 384 distribution events; 1 unit was returned leaving 383 units . Lot/code info: lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.