Drug recall
TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa…
FDA recall event 83820 · Class II · TriMed Inc.
Key facts
| Event ID | 83820 |
|---|---|
| Recall numbers | Z-0355-2020, Z-0356-2020, Z-0357-2020, Z-0358-2020, Z-0359-2020 |
| Recalling firm | TriMed Inc. |
| Product type | Devices |
| Products | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA., TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA., TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA., TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA., TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The epoxy on Apex manufactured epoxy-coated instruments can pop off., The spring on the PEG-Extender can rust due to the type of steel used to manufacture it., The WHD/WHV impactors can rust over time due to an improper manufacturing process. |
| Initiation date | Sep 28, 2018 |
| Report date | Nov 20, 2019 |
| City | Santa Clarita |
| State | CA |
| Country | United States |
| FEI number | 3001236812 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: