FDA recall Z-3176-2018

Product

Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-07-20

Report date

2018-09-26

Termination date

2020-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3176-2018