Device recall
Z-2056-2013: Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting…
FDA device recall · Class II · Integra Limited
Key facts
| Recall number (Z-number) | Z-2056-2013 |
|---|---|
| Recall event | 65824 |
| Product | Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery. |
| Product code | HBG |
| Recalling firm | Integra Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 1, 2014 |
| 510(k) numbers | K902818 |
| FEI number | 3001700044 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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