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
Reported: November 6, 2019 Initiated: September 6, 2018 #Z-0261-2020
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.
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing, LLC
- Units Affected
- 107 Scan Adapters
- Distribution
- US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia,
- Location
- Westlake Village, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 107 Scan Adapters.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2019. Severity: Moderate. Recall number: Z-0261-2020.
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