Paltop Scan Abutment SP Recalled for Dimensional Tolerance Deviations
Paltop Advanced Dental Solutions is recalling Scan Abutment SP devices due to manufacturing tolerance deviations that may delay dental restoration. Affected devices showed orientation misalignment and size engraving errors.
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 of a dental scanning device with manufacturing tolerance deviations. No reported injuries, illnesses, or adverse events are described. The identified hazard is functional delay in restoration, not a direct patient safety risk.
Plain-English summary
Paltop Advanced Dental Solutions is recalling Scan Abutment SP (Catalog Number 30-70101), a dental device used to create digital impressions of dental implants and abutment platforms during surgical and restorative procedures.
The recall was issued because some devices are manufactured outside tolerance specifications. Specifically, certain units showed a maximum 2-degree deviation in the orientation between the PEEK head and titanium base, and a size engraving incongruence has been identified. These deviations may delay the final dental restoration process.
The recall affects 782 units that were manufactured prior to July 21, 2021, and distributed nationwide in the United States.
The recalled product
- Product
- Scan Abutment SP, Cat. No. 30-70101 - 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 surgical
- Manufacturer
- Paltop Advanced Dental Solutions Ltd
- Hazard
- dimensional-deviation
- manufacturing-defect
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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