Device recall
Z-0217-2009: Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile)…
FDA device recall · Class III · Stryker Spine
Key facts
| Recall number (Z-number) | Z-0217-2009 |
|---|---|
| Recall event | 49441 |
| Product | Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ. The bone screw (Reference # 48694014) is a 04.0 x 14mm used to attach the Reflex Hybrid Anterior Cervical Plate (ACP)… |
| Product code | KWQ |
| Recalling firm | Stryker Spine |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 19, 2009 |
| 510(k) numbers | K040261 |
| 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