Device product

Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629

Z-3177-2018

July 20, 2018

Class II

Product summary

Firm: Zimmer Biomet, Inc.
Event: Event 80843
Status: Terminated
Classification: Class II
Quantity: 52
Official record key: device-enforcement:Z-3177-2018

Official wording

Reason: The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.

Code information: Lot Number 625450, UDI (1)00880304421066(17)221019(10)625450

Distribution pattern: The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.