Implant Direct Scan Adapter Assembly Recalled for Incorrect Assembly
Implant Direct is recalling 107 Scan Adapter Assemblies due to incorrect assembly that may prevent clinicians from capturing implant positions, causing patient delays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect leading to patient delay rather than direct physical injury or death, fitting the Moderate severity criteria for low-risk issues without reported harm.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 107 Scan Adapter Assemblies for the Replant platform. The affected part numbers are 6035-09PT-M, 6043-09PT-M, and 6050-09PT-M, with specific lot numbers 104539, 104540, and 104511. These products were distributed in the United States and in Canada and Australia.
The recall was initiated because of incorrect assembly of the scan adapters. This defect could prevent clinicians from capturing the position and orientation of dental implants or lab analogs during the digital scanning process. The primary consequence of this failure is a delay in patient care.
Clinicians and patients should check their inventory for the specific part numbers and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to their instructions.
The recalled product
- Product
- 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
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Affected units
- 107
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part numbers/Lot Numbers: 6035-09PT/Lot # 104539
- 6043-09PT/ Lot # 104540
- 6050-09PT/Lot # 104511
Distribution
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