Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra or...
FDA Device Recall #Z-0018-2022 — Class II — July 26, 2021
Recall Summary
| Recall Number | Z-0018-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 26, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Paltop Advanced Dental Solutions Ltd |
| Location | Caesarea |
| Product Type | Devices |
| Quantity | 236 |
Product Description
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 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.
Reason for Recall
Some 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.
Distribution Pattern
US Nationwide distribution. No foreign distribution from US.
Lot / Code Information
All lots manufactured prior to July 21, 2021.
Other Recalls from Paltop Advanced Dental Solutions Ltd
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0013-2022 | Class II | Scan Abutment SP, Cat. No. 30-70101 - Product U... | Jul 26, 2021 |
| Z-0014-2022 | Class II | Scan Abutment NP, Cat. No. 30-70102 - Product U... | Jul 26, 2021 |
| Z-0015-2022 | Class II | Scan Abutment MU, Cat. No. 30-70103 - Product ... | Jul 26, 2021 |
| Z-0016-2022 | Class II | Scan Abutment SU, Cat. No. 30-70104 - Product ... | Jul 26, 2021 |
| Z-0017-2022 | Class II | Scan Abutment PCA, Cat. No. 30-70105 - Product... | Jul 26, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.