Device product
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
Z-0823-2022
Product summary
- Event
- Event 89721
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31 eaches
- Official record key
device-enforcement:Z-0823-2022
Official wording
Reason: NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
Code information: Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.
Derived failure modes
-
Unknown
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair