Device recall
Z-1795-2012: Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-1795-2012 |
|---|---|
| Recall event | 61717 |
| Product | Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities… |
| Product code | MQV |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 14, 2013 |
| 510(k) numbers | K063124 |
| FEI number | 3003418325 |
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