Device recall
Z-0559-2013: MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The…
FDA device recall · Class II · Integra LifeSciences Corporation
Key facts
| Recall number (Z-number) | Z-0559-2013 |
|---|---|
| Recall event | 63776 |
| Product | MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary. |
| Product code | HBL |
| Recalling firm | Integra LifeSciences Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 21, 2014 |
| 510(k) numbers | K120633 |
| FEI number | 3004608878 |
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