Recall Z-0752-2019 ยท NPM Bone Grafting Material, Animal Source
Collagen Matrix Inc
Porcine Anorganic Bone Mineral 4.0cc
| Date | Oct 30, 2018 |
| Status | Terminated |
| Reason | There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled. |
| Root cause | Employee error |
| Action | On October 30, 2018 Collagen Matrix, notified their 2 distributors of the issue via email. The two distributors provided notices to their customers. Customers were advised to take the following actions: 1. If any of the items noted in the scope of the letter is held in stock, please return them along with a copy of the letter to the address provided. Replacement product will be provided upon receipt of the return. 2. Complete the Certificate of Acknowledgement within 15 days of receipt and email the completed form to the email address noted within your letter. |
| Quantity | 136 units |
| Distribution | FL, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140714 | PORCINE ANORGANIC BONE MINERAL Collagen Matrix, Inc., Jul 16, 2014 |