Z-0356-2020 Class II Ongoing

Recalled by TriMed Inc. — Santa Clarita, CA

Recall Details

Product Type
Devices
Report Date
November 20, 2019
Initiation Date
September 28, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,042 drill guides

Product Description

TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, 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 Pattern

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

Code Information

Lot numbers 3168, 3464, 3660, 3963, and 4216.