The Recall Desk
HighFDA (Devices)·Z-0015-2022·Announced 2021-10-13

Paltop Scan Abutment MU devices recalled for manufacturing tolerance deviations

Paltop Advanced Dental Solutions is recalling 337 Scan Abutment MU devices due to manufacturing tolerance deviations in orientation and sizing that may delay dental restoration procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving manufacturing tolerance deviations in a precision dental scanning component that could affect the accuracy of digital impressions. Though no illnesses or injuries have been reported, out-of-tolerance devices present a risk of harm to restoration quality and patient outcomes if inaccurate scans result in poorly fitting prosthetics, fitting the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

The recall affects Scan Abutment MU devices (catalog number 30-70103) manufactured by Paltop Advanced Dental Solutions Ltd. These devices are used to take digital impressions of dental implants or abutment platforms using intraoral or optical scanners. All devices manufactured prior to July 21, 2021 are affected, representing 337 units distributed nationwide throughout the United States.

The devices being recalled are outside of manufacturing tolerances. Some units exhibit a maximum deviation of 2 degrees in the orientation between the PEEK head and titanium base components. Additionally, inconsistencies have been identified between the size engraved on the PEEK component and the actual dimensions. These deviations may delay the final restoration process.

Consumers who have received one of these devices should contact their dental provider to determine if they have an affected device and discuss whether replacement or other remedial action is necessary.

The recalled product

Product
Scan Abutment MU, Cat. No. 30-70103 - 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
Category
Medical Device — Dental Implant Component
Hazard
  • tolerance-deviation
  • component-misalignment
  • size-mismatch

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.

Related recalls

Same category