FDA recall Z-2685-2020

Product

TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.

Reason for recall

A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.

Distribution

International distribution in the countries of Brazil, Colombia and United Arab Emirates.

Key facts

Status

Terminated

Initiation date

2020-06-24

Report date

2020-07-29

Termination date

2021-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2685-2020