Scan Abutment NP Dental Implant Components Recalled for Dimensional Deviations
Paltop Advanced Dental Solutions is recalling Scan Abutment NP dental implant components due to manufacturing tolerance deviations that may affect implant restoration fit and timing.
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, illnesses, or safety incidents. The identified manufacturing tolerance deviations affect device fit and function but do not present an explicit safety hazard.
Plain-English summary
Paltop Advanced Dental Solutions Ltd is recalling Scan Abutment NP devices (Category Number 30-70102). These are dental implant scanning components used to take digital impressions for implant and abutment positioning during surgical and restorative procedures.
Manufacturing deviations have been identified in some devices produced prior to July 21, 2021. Specifically, the orientation between the peek (plastic) head and titanium base may deviate by up to 2 degrees, and the size engraving on the peek component may be incorrect. These deviations may delay the final restoration process.
Approximately 354 devices were distributed nationwide in the United States. The recall affects devices from all lots manufactured before July 21, 2021.
Healthcare providers and dental professionals who have used or received these devices should contact Paltop Advanced Dental Solutions Ltd for instructions on device replacement or further management.
The recalled product
- Product
- Scan Abutment NP, Cat. No. 30-70102 - 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
- alignment-issue
- size-engraving-error
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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