Z-0261-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- September 6, 2018
- Termination Date
- July 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 107 Scan Adapters
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.
Distribution Pattern
US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia,
Code Information
Part numbers/Lot Numbers: 6035-09PT/Lot # 104539; 6043-09PT/ Lot # 104540; 6050-09PT/Lot # 104511