Scan Abutment PCA dental implant component recalled for tolerance deviations
Paltop Advanced Dental Solutions is recalling Scan Abutment PCA devices due to manufacturing tolerance deviations that may delay implant restoration. Some devices show up to 2-degree orientation variance and sizing discrepancies.
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: This is an FDA Class II medical device recall with manufacturing tolerance deviations, but the source text does not report any patient illnesses, injuries, or hospitalizations. The stated consequence—delayed restoration—is a functional issue rather than a direct safety hazard.
Plain-English summary
Paltop Advanced Dental Solutions Ltd is recalling Scan Abutment PCA devices (Cat. No. 30-70105). These devices are used with intraoral or optical scanners to create digital impressions for dental implant placement and restoration.
The recall involves 68 units manufactured prior to July 21, 2021, and distributed nationwide in the United States. Some devices were found to be outside manufacturing tolerances, with deviations of up to 2 degrees in the orientation between the peek head and titanium base, and discrepancies in the size markings on the peek component.
These manufacturing deviations may delay the final restoration process. Patients and practitioners with this device should contact Paltop Advanced Dental Solutions Ltd for instructions on product returns or replacements.
The recalled product
- Product
- Scan Abutment PCA, Cat. No. 30-70105 - 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…
- Manufacturer
- Paltop Advanced Dental Solutions Ltd
- Category
- Medical Device — Dental Implant
- Affected units
- 68
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.
Part of a larger recall action
This product is one of 6 recalled by Paltop Advanced Dental Solutions Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Paltop Advanced Dental Solutions Ltd
See all →- ModerateDental implant abutments recalled for orientation and sizing tolerance issues
FDA (Devices) · 2021-10-13
- HighPaltop Scan Abutment MU devices recalled for manufacturing tolerance deviations
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- ModerateDental implant scan abutment recalled for dimensional tolerance and marking defects
FDA (Devices) · 2021-10-13
- ModeratePaltop Scan Abutment SP Recalled for Dimensional Tolerance Deviations
FDA (Devices) · 2021-10-13
- ModerateScan Abutment NP Dental Implant Components Recalled for Dimensional Deviations
FDA (Devices) · 2021-10-13
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