Drug recall
TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation…
FDA recall event 82209 · Class II · TriMed Inc.
Key facts
| Event ID | 82209 |
|---|---|
| Recall numbers | Z-1214-2019 |
| Recalling firm | TriMed Inc. |
| Product type | Devices |
| Products | TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The bone screw is shorter than the intended design specification. |
| Initiation date | Aug 24, 2018 |
| Report date | May 1, 2019 |
| Termination date | Dec 28, 2020 |
| 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: