Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN ...
FDA Device Recall #Z-0707-2020 — Class II — December 6, 2018
Recall Summary
| Recall Number | Z-0707-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 6, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Navigation, Inc. |
| Location | Louisville, CO |
| Product Type | Devices |
| Quantity | 1,297 percutaneous pin adapters |
Product Description
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.
Reason for Recall
Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.
Distribution Pattern
Distribution was nationwide. There was government/military/foreign distribution.
Lot / Code Information
Percutaneous pin adapter lot numbers: 150114, 150505, 150506, 150904, 151005, 151007 160201, 160224, 160419, 160617, 160707, 170216, 180110, and 180409.
Other Recalls from Medtronic Navigation, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1022-2025 | Class II | Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: ... | Dec 4, 2024 |
| Z-0050-2025 | Class II | StealthStation S8 App versions 1.3.0 and 1.3.2,... | Aug 22, 2024 |
| Z-1776-2024 | Class I | Stealth S8 Clinical Software Application, REF: ... | Mar 26, 2024 |
| Z-0698-2024 | Class II | Medtronic, REF 9733235, Pin, 100mm, STERILE, PE... | Nov 28, 2023 |
| Z-0699-2024 | Class II | Medtronic, REF 9733236, Pin, 150mm, STERILE, PE... | Nov 28, 2023 |
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.