NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
- Company
- Ace Surgical Supply Co., Inc.
- Recall Initiated
- February 2, 2022
- Recall Number
- Z-0823-2022
- Quantity
- 31 eaches
- Firm Location
- Brockton, MA
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
Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.
Lot / Code Info
Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264
Root Cause
Under Investigation by firm
Action Taken
Ace Surgical issued Urgent Voluntary Recall letter dated 2/4/22 to US customers via certified mail and customers outside of US contacted via email. Letter states reason for recall, health risk and action to take: Please refer to the lot number on the outer box label. The lot in question is BMBU21A 1. If you confirm this lot number on ACE Surgical Supply product, DO NOT USE THE PRODUCT and segregate it to prevent future use. Please be advised that the recalled lot identified was from a specific batch produced in October 2021. If you have received this notification, our shipping records confirm that you received this specific batch that was affected. All products subject to this RECALL will need to be returned to ACE Surgical. Please complete the RESPONSE form and follow the instructions for submission. If you do have product to be returned, please return the response form to doreenprice@acesurgical.com. If you do have inventory to return, once the response form is received and confirmed, an ARS Label will be issued. If you have any further questions, please contact Doreen Price 508-588-3100, Extension 781 or doreen price@acesurgical .com.