Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
FDA Device Recall #Z-0699-2024 — Class II — November 28, 2023
Recall Summary
| Recall Number | Z-0699-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 28, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Navigation, Inc. |
| Location | Lafayette, CO |
| Product Type | Devices |
| Quantity | 4,224 |
Product Description
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Reason for Recall
Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Oman, Portugal, Spain, Switzerland, United Kingdom.
Lot / Code Information
UDI: 00613994247865 and 00643169105669(Japan)/ Serial Numbers: 2023041143, 2023051122, 2023051457, 2023051458, 2023060918, 2023051459, 2022030438, 2023041136, 2023041141
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-0188-2024 | Class I | StealthStation S8 Application version 2.0 and 2... | Sep 27, 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.