FDA Device recall Z-0356-2020
TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA
- FDA Device
- Class II
- ongoing
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA by Trimed, citing the epoxy on Apex manufactured epoxy-coated instruments can pop off.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0356-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-09-28 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Trimed |
| Distribution | US |
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.
Reason
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Identifiers
| code_info | Lot numbers 3168, 3464, 3660, 3963, and 4216. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0356-2020%22
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