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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Navigation, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1022-2025
Related Recalls
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Medtronic Navigation
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.