Dental implant scan abutment recalled for dimensional tolerance and marking defects
Paltop Scan Abutment WP dental implant scanning devices are recalled due to manufacturing defects. Affected units show dimensional tolerance deviations and size marking incongruences that may delay restoration procedures.
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 device recall with no reported injuries or adverse events. The defect is a manufacturing tolerance deviation affecting device precision and fit, not an acute safety hazard. The stated consequence is procedural delay, not patient harm.
Plain-English summary
Paltop Advanced Dental Solutions Ltd is recalling Scan Abutment WP devices (Catalog No. 30-70106). These devices are used to take digital impressions of dental implants for restorative applications.
Affected devices have been found outside tolerance specifications. The devices show maximum angular deviations of 2 degrees in the orientation between the peek head and titanium base, and incongruences between the size engraved on the peek head. These deviations may delay final restoration procedures.
The recall affects 236 units manufactured prior to July 21, 2021, distributed nationwide in the United States.
The recalled product
- Product
- Scan Abutment WP, Cat. No. 30-70106 - 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
- 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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