Class 2 Device Recall NuOss Collagen Block

• Date Initiated by Firm: February 02, 2022
• Create Date: March 24, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0823-2022
• Recall Event ID: 89721
• 510(K)Number: K043034
• Product Classification: Bone grafting material, animal source - Product Code NPM
• Product: NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
• Code Information: Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264
• FEI Number: 1287163
• Recalling Firm/ Manufacturer: Ace Surgical Supply Co., Inc.; 1034 Pearl St; Brockton MA 02301-5411
• For Additional Information Contact: SAME; 800-441-3100
• Manufacturer 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
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 31 eaches
• Distribution: Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NPM