Drug recall
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
FDA recall event 89771 · Class II · Acumed LLC
Key facts
| Event ID | 89771 |
|---|---|
| Recall numbers | Z-0958-2022, Z-0959-2022 |
| Recalling firm | Acumed LLC |
| Product type | Devices |
| Products | 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010, 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments… |
| Initiation date | Mar 9, 2022 |
| Report date | Apr 27, 2022 |
| City | Hillsboro |
| State | OR |
| Country | United States |
| FEI number | 1000125930 |
At a glance
- 1–9 Products in this recall
- 1–9 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: