FDA Recall
Terminated
NuOSS Cancellous Intended for use in dental surgery.
Recall: Z-1096-2016
·
Initiated August 25, 2015
Recall
- Recall Number
- Z-1096-2016
- Event Number
- 73222
- Firm
- Collagen Matrix Inc
- FEI Number
- 3003300673
- Product Code
- NPM
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- August 25, 2015
- Terminated
- May 11, 2016
- Address
- 509 Commerce St, Franklin Lakes, NJ, 07417-1374
Description
NuOSS Cancellous Intended for use in dental surgery.
Reason
On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.
Action
Collagen Matrix Inc. notified their sole customer on November 17, 2015. On August 25, 2015, during a review of inventory, tt was discovered that of the 171 units product shipped, 19 units may have been the incorrect size. For further questions please call (201) 405-1477
Distribution
US Distribution to the state of : MA
Quantity
171 units