Device product
TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Z-0356-2020
Product summary
- Firm
- TriMed Inc.
- Event
- Event 83820
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,042 drill guides
- Official record key
device-enforcement:Z-0356-2020
Official wording
Reason: The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Code information: Lot numbers 3168, 3464, 3660, 3963, and 4216.
Distribution pattern: Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
Derived failure modes
-
Unknown
The epoxy on Apex manufactured epoxy-coated instruments can pop off.