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Recall Observatory FDA recall evidence

Device 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.

Z-0590-2016

December 03, 2015

Class II

Product summary

Firm
Zimmer Manufacturing B.V.
Event
Event 72750
Status
Terminated
Classification
Class II
Quantity
384 distribution events; 1 unit was returned leaving 383 units .
Official record key
device-enforcement:Z-0590-2016

Official wording

Reason: 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.

Code information: lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)

Distribution pattern: Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.