Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANE...
FDA Device Recall #Z-1022-2025 - Class II, December 4, 2024
Recall Summary
| Recall Number | Z-1022-2025 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 4, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Navigation, Inc. |
| Location | Lafayette, CO |
| Product Type | Devices |
| Quantity | 67,370 pins |
Product Description
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.
Reason for Recall
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Czech Republic, Denmark, Finland, Germany, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Arab Emirates, United Kingdom, Vietnam.
Lot / Code Information
Sterile Percutaneous Pin, 100mm Product Number: 9733235 UDI-DI code: 00613994247872 Serial/Lot Numbers: 2023071142 2023080327 2023080330 2023091351 2023091353 2023091354 2023091355 2023091356 2023100459 2023100460 2023101139 2023101140 2023101470 2023101472 2023101473 2023110368 2023110370 2023110371 2023110821 2023110823 2023110824 2023111489 2023111490 2023111491 2023120008 2023120009 2023120434 2023120834 2023120835 2023121177 2024010330 2024010332 2024011153 2024021011 2024021014 2024021015 2024021016 2024021100 2024021103 2024021365 2024040327 2024040895 2024040896 2024050686 2024050687 2024050688 2024051221 2024051222 2024051225 2024051226 2024060262 2024060479 2024060480 2024060484 2024070408 2024070409 2024070410 2024070411 2024070414 2024070415 2024080529 2024080530 GTIN code (Japan only): 00643169105676 Serial/Lot Numbers: 2023091351 2023100459 2023101140 2023101472 2023101473 Sterile Percutaneous Pin, 150mm Product Number: 9733236 UDI-DI code: 613994247865 Serial/Lot Numbers: 2023071143 2023071144 2023091357 2023091358 2023091359 2023091360 2023101141 2023101142 2023101471 2023110372 2023110373 2023110822 2023111492 2023120010 2023120039 2023120040 2023120041 2023120042 2023120431 2023120432 2023120433 2023120831 2023120832 2023121178 2024010333 2024010334 2024011154 2024011155 2024021012 2024021013 2024021101 2024021102 2024021364 2024021366 2024021367 2024040325 2024040328 2024040897 2024040898 2024050689 2024051224 2024060263 2024060481 2024060482 2024060483 2024070413 2024070416 2024070417 2024080534 2024080535 GTIN code (Japan only): 643169105669 Serial/Lot Numbers: 2023071143 2023071144 2023101142 2023110822 2023120010
Other Recalls from Medtronic Navigation, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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 |
| 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.