Recall Z-0261-2020— Implant Direct Sybron Manufacturing, LLC
Class II · Terminated
Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2018-09-06, terminated 2021-07-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. 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..
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-06
- Terminated
- 2021-07-01
- Firm location
- Westlake Village, CA, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.