Recall Z-1096-2016
Collagen Matrix Inc · initiated August 25, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NuOSS Cancellous Intended for use in dental surgery.
Codes / lots: Reference No. BM2C20010-U Lot no. BM2CU15E2
Reason for recall
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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
Details
- Recall number
- Z-1096-2016
- Initiated
- August 25, 2015
- Terminated
- May 11, 2016
- Product code
- NPM – Bone Grafting Material, Animal Source
- Quantity
- 171 units
- Distribution
- US Distribution to the state of : MA
- Recalling firm
- Collagen Matrix Inc, Franklin Lakes, NJ