Implant Direct Scan Adapter Assembly Replant platform recall
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M…
Why was Implant Direct Scan Adapter Assembly Replant platform 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part numbers/Lot Numbers: 6035-09PT/Lot # 104539; 6043-09PT/ Lot # 104540; 6050-09PT/Lot # 104511
- Product
- Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M…
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 107 Scan Adapters
- Distribution
- US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia,
- Recall date
- November 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)