Recall Z-1173-2016 ยท NPM Bone Grafting Material, Animal Source
Collagen Matrix Inc
ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -Filling of periodontal defects in conjunction with produc
| Date | Nov 17, 2015 |
| Status | Terminated |
| Reason | The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine. |
| Root cause | Component design/selection |
| Action | Collagen Matrix Inc. notified their sole customer on 11/17/2015. |
| Quantity | 200 units |
| Distribution | US in the state of 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 |