Drug recall
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832…
FDA recall event 84664 · Class II · Stryker Corporation
Key facts
| Event ID | 84664 |
|---|---|
| Recall numbers | Z-1147-2020, Z-1148-2020 |
| Recalling firm | Stryker Corporation |
| Product type | Devices |
| Products | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197, Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result… |
| Initiation date | Jul 19, 2019 |
| Report date | Feb 19, 2020 |
| Termination date | Feb 2, 2024 |
| City | San Jose |
| State | CA |
| Country | United States |
| FEI number | 2936485 |
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: