Recall Z-0261-2020 ยท NDP Accessories, Implant, Dental, Endosseous
Implant Direct Sybron Manufacturing, LLC
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
| Date | Sep 6, 2018 |
| Status | Terminated |
| Reason | The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient. |
| Root cause | Nonconforming Material/Component |
| Action | On X/xx/xxx, consignees were mailed a "Urgent: Medical Device Recall" letter via XXX. The recall notification asked customers to do the following: 1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement Form within 48 hours for the product listed above; Quarantine product and return product listed above. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within |
| Quantity | 107 Scan Adapters |
| Distribution | US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.