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Implant Direct Sybron Manufacturing, LLC recalls Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 1084130
Recalled November 6, 2019 · FDA recall Z-0261-2020 · Implant Direct Sybron Manufacturing
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. · FDA Class II
Units
107 Scan Adapters
Sold at
US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia,
Description
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.
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
Manufacturer(s)
Implant Direct Sybron Manufacturing, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →