FDA recall Z-0358-2020

TriMed Inc. · Class II · device

Product

TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Reason for recall

The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.

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-0358-2020