Recall Z-0986-2012 ยท MQV Filler, Bone Void, Calcium Compound
Integra LifeSciences Corp
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 with bone during the healing process.
| Date | Feb 8, 2012 (initiated Oct 7, 2011) |
| Status | Terminated |
| Reason | Integra OS Osteoconductive Putty is labeled with incorrect storage conditions. |
| Root cause | Error in labeling |
| Action | Integra issued an "Urgent: Product Recall Notification" to customers and sales specialists on 10/7/2011. They were advised of the problem and provided instructions on how to handle the affected product. |
| Quantity | 45 units |
| Distribution | Nationwide Distribution - Including the states of CA, OK, MD and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062353 | MOZAIK BONE REGENERATION MATRIX - PUTTY Integra LifeSciences Corporation, Dec 20, 2006 |