Device recall
Z-0986-2012: Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty…
FDA device recall · Class II · Integra LifeSciences Corp
Key facts
| Recall number (Z-number) | Z-0986-2012 |
|---|---|
| Recall event | 60938 |
| Product | Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced… |
| Product code | MQV |
| Recalling firm | Integra LifeSciences Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2013 |
| 510(k) numbers | K062353 |
| 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