Z-0261-2020 Class II Terminated
FDA device recall Z-0261-2020 was initiated by Implant Direct Sybron Manufacturing, LLC on September 6, 2018 and is designated Class II. 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… The recall status is terminated (terminated July 1, 2021). Affected quantity: 107 Scan Adapters.
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