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
- Recall Initiated
- September 6, 2018
- Terminated
- July 1, 2021
- Recall Number
- Z-0261-2020
- Quantity
- 107 Scan Adapters
- Firm Location
- Westlake Village, CA
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,
Lot / Code Info
Part numbers/Lot Numbers: 6035-09PT/Lot # 104539; 6043-09PT/ Lot # 104540; 6050-09PT/Lot # 104511
Root Cause
Nonconforming Material/Component
Action Taken
On X/xx/xxx, consignees were mailed a "Urgent: Medical Device Recall" letter via XXX. The recall notification asked customers to do the following: 1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement Form within 48 hours for the product listed above; Quarantine product and return product listed above. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification. 4. If you have any of the affected product, please return the product and we will send you a replacement part. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. 5.If you or your patients has experienced any issues as a result of the affected products noted in this communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm