Recall Z-0823-2022 ยท NPM Bone Grafting Material, Animal Source
Ace Surgical Supply Co., Inc.
NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
| Date | Feb 2, 2022 |
| Status | Open, Classified |
| 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 |
| Root 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 |
| Quantity | 31 eaches |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043034 | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS Collagen Matrix, Inc., Aug 4, 2005 |