Device recall
Z-1147-2020: Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF…
FDA device recall · Class II · Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1147-2020 |
|---|---|
| Recall event | 84664 |
| Product | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197 |
| Product code | MBI |
| Recalling firm | Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2024 |
| 510(k) numbers | K181083 |
| FEI number | 2936485 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database