TriMed Olecranon Hook Plate — Class II medical device recall Z-0366-2020
Terminated recall by TriMed Inc., reported 2019-11-20, distributed nationwide. The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modifi
| Recall number | Z-0366-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TriMed Inc., Santa Clarita, CA, United States |
| Recall initiated | 2018-08-15 |
| Classified | 2019-11-13 |
| Reported by FDA | 2019-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 583 bone |
| UPC / GTIN / UDI-DI | 00842188101281 |
| Lot numbers | 110631 |
| Model numbers | OHOOKL-6 |
Product
TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.
Reason for recall
The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.
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-0366-2020. 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.