FDA recall Z-0261-2020

Implant Direct Sybron Manufacturing, LLC · Class II · device

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 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.

Distribution

US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia,

Key facts

Status: Terminated
Initiation date: 2018-09-06
Report date: 2019-11-06
Termination date: 2021-07-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Westlake Village, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0261-2020