Product Safety Recalls

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Paltop Advanced Dental Solutions Ltd Recall 88576

Description: 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 and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Paltop Advanced Dental Solutions Ltd Recall 88576 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0014-2022
Event ID88576
Event DescriptionScan 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 and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Product TypeDevices
DistributionUS Nationwide distribution. No foreign distribution from US.
Quantity354
Recall ReasonSome devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
Device Classification20211013
Device Code InfoAll lots manufactured prior to July 21, 2021.
Center Classification Date20211004
Recall Initiation Date20210726
Recalling FirmPaltop Advanced Dental Solutions Ltd
Initial Notification Letter
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