Device product
NuOSS Cancellous Intended for use in dental surgery.
Z-1096-2016
Product summary
- Event
- Event 73222
- Status
- Terminated
- Classification
- Class II
- Quantity
- 171 units
- Official record key
device-enforcement:Z-1096-2016
Official wording
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.
Code information: Reference No. BM2C20010-U Lot no. BM2CU15E2
Distribution pattern: US Distribution to the state of : MA
Derived failure modes
-
Unknown
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.