NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)0...
FDA Device Recall #Z-1851-2020 — Class II — August 28, 2019
Recall Summary
| Recall Number | Z-1851-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 28, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nobel Biocare Usa Llc |
| Location | Yorba Linda, CA |
| Product Type | Devices |
| Quantity | 228 pieces |
Product Description
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Reason for Recall
The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
Distribution Pattern
International distribution - the country Russia only.
Lot / Code Information
Lot:12129104
Other Recalls from Nobel Biocare Usa Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0658-2022 | Class II | NobelReplace Conical Connection RP 4.3x11.5 mm ... | Dec 17, 2021 |
| Z-1853-2020 | Class II | Temporary Abutment Engaging CC RP pre-manufactu... | Aug 9, 2019 |
| Z-1855-2020 | Class II | Snappy Abutment 5.5 CC RP 3 mm; pre-manufacture... | Aug 9, 2019 |
| Z-1854-2020 | Class II | Esthetic Abutment CC RP 1.5 mm pre-manufactured... | Aug 9, 2019 |
| Z-1856-2020 | Class II | Universal Base CC RP 1.5 mm; The Universal Base... | Aug 9, 2019 |
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.