Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Implant Direct Scan Adapter Assembly Replant platform for the following Recalled by Implant Direct Sybron Manufacturing, LLC Due to The action is being initiated due to incorrect...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Implant Direct Sybron Manufacturing, LLC directly.
Affected Products
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
Quantity: 107 Scan Adapters
Why Was This 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.
Where Was This Sold?
This product was distributed to 14 states: CA, CO, FL, GA, LA, MA, NE, NJ, NY, OH, PA, SC, UT, VA
About Implant Direct Sybron Manufacturing, LLC
Implant Direct Sybron Manufacturing, LLC has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report