FDA Device recall Z-0355-2020
TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, 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 Countersink 1.7mm, HCS, REF HSINK-1.7, 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-0355-2020 |
| 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 Countersink 1.7mm, HCS, REF HSINK-1.7, 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 number 91401455 |
|---|
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-0355-2020%22
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