Recall Z-2897-2016 ยท EIH Powder, Porcelain
Prismatik Dentalcraft, Inc
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
| Date | Aug 15, 2016 |
| Status | Terminated |
| Reason | Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Prismatik DentalCraft, Inc. sent an Urgent Medical Device Recall letter dated August 15, 2016, to all their customers to inform them that Prismatik Dentalcraft is recalling BruxZir NOW product because the new design was manufactured at risk and was supposed to be quarantined and held until validation was completed. Prismatik failed to properly identify the implicated lots as quarantined product. Customers are informed that the BruxZir Now with the thicker sprue design was packaged and shipped to customers in error. Customers are informed of that there is no risk to the patient and of the ac |
| Quantity | 150 units |
| Distribution | Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130924 | BRUXZIR SHADED Prismatik Dentalcraft, Inc., May 16, 2013 |