FDA recall Z-0357-2020

Product

TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Reason for recall

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

Distribution

Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.

Key facts

Status

Ongoing

Initiation date

2018-09-28

Report date

2019-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0357-2020