Dental implant abutments recalled for orientation and sizing tolerance issues
Paltop Advanced Dental Solutions is recalling Scan Abutment SU devices (Catalog No. 30-70104) manufactured before July 21, 2021, due to manufacturing tolerance deviations that may delay dental restoration.
What this means for you
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: FDA Class II recall with no reported injuries or adverse events. The issue involves manufacturing tolerance deviations affecting device orientation and sizing, with the stated consequence being delayed restoration rather than direct patient harm. Without reported adverse events, this is classified as Moderate per the severity rubric.
Plain-English summary
Paltop Advanced Dental Solutions Ltd is recalling certain Scan Abutment SU (Catalog No. 30-70104) devices manufactured prior to July 21, 2021. These devices are used to take impressions with intra-oral or optical scanners to provide digital registration of dental implant platforms. The recalled devices were distributed nationwide in the United States.
Some devices are outside manufacturing tolerances. Affected devices showed deviations up to 2 degrees in the orientation between the peek head and titanium base. Additionally, an incongruence was identified between the size engraved on the peek component and the actual size. These deviations may delay the final dental restoration.
Patients and dental providers with devices manufactured prior to July 21, 2021, should contact Paltop Advanced Dental Solutions to determine whether their device is affected and to discuss any necessary actions.
The recalled product
- Product
- Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
- Manufacturer
- Paltop Advanced Dental Solutions Ltd
- Hazard
- dimensional-tolerance
- sizing-discrepancy
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 (2)
- All lots manufactured prior to July 21
- 2021.
Distribution
Distributed nationwide across the United States.
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