Z-0823-2022 Class II Ongoing
FDA device recall Z-0823-2022 was initiated by Ace Surgical Supply Co., Inc. on February 2, 2022 and is designated Class II. Reason for recall: NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair The recall status is ongoing. Affected quantity: 31 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2022
- Initiation Date
- February 2, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 eaches
Product Description
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
Reason for Recall
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.
Code Information
Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264