PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 26, 2018 Initiated: July 20, 2018 #Z-3177-2018

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
52
Distribution
The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629. Recalled by Zimmer Biomet, Inc.. Units affected: 52.
Why was this product recalled?
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3177-2018.