NexGEN System recall
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…
Why was NexGEN System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)
- 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…
- Recalling firm
- Zimmer Manufacturing B.V.
- Quantity
- 384 distribution events; 1 unit was returned leaving 383 units .
- Distribution
- Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.
- Recall date
- January 13, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)