Device recall
Z-0763-2010: Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile; Manufactured by…
FDA device recall · Class II · Stryker Spine
Key facts
| Recall number (Z-number) | Z-0763-2010 |
|---|---|
| Recall event | 54169 |
| Product | Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile; Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ. The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing… |
| Product code | KWQ |
| Recalling firm | Stryker Spine |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 6, 2012 |
| 510(k) numbers | K062310 |
| FEI number | 3004024955 |
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