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.
This recall has been terminated (originally issued February 8, 2012).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- October 7, 2011
- Posted
- February 8, 2012
- Terminated
- May 21, 2013
- Recall Number
- Z-0986-2012
- Quantity
- 45 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
Distribution
Nationwide Distribution - Including the states of CA, OK, MD and VA.
Lot / Code Info
2.5 cc Part numbers - IOS10125 Lot numbers - N199416 and 215944 5 cc Part numbers - lOS10155 Lot numbers - 208500, 206504 and N216026
Root Cause
Error in labeling
Action Taken
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.