FDASeptember 6, 2018device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
implant direct sybron manufacturingimplantimplant direct
UPCs
108413071239341084130712394110841307123958
Recall history
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