TriMed Countersink 1 — Class II medical device recall Z-0355-2020
Ongoing recall by TriMed Inc., reported 2019-11-20, distributed nationwide. The epoxy on Apex manufactured epoxy-coated instruments can pop off.
| Recall number | Z-0355-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TriMed Inc., Santa Clarita, CA, United States |
| Recall initiated | 2018-09-28 |
| Classified | 2019-11-12 |
| Reported by FDA | 2019-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, SE, ZA |
| Quantity | 99 instruments |
| Lot numbers | 91401455 |
| Model numbers | HSINK-1.7 |
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 for recall
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0355-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.