Device recall
Z-1697-2014: Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number…
FDA device recall · Class II · Integra LifeSciences Corporation
Key facts
| Recall number (Z-number) | Z-1697-2014 |
|---|---|
| Recall event | 68284 |
| Product | Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or… |
| Product code | HWC |
| Recalling firm | Integra LifeSciences Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2016 |
| 510(k) numbers | K073375 |
| FEI number | 1121308 |
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