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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medtronic Percutaneous Reference Pins Recalled for Improper Fit

Agency Publication Date: January 27, 2025
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Summary

Medtronic Navigation, Inc. is recalling approximately 67,370 Sterile Percutaneous Reference Pin Sets because the pins may not fit into the patient reference frame or the percutaneous pin adapter during surgery. This recall involves the 100mm (Product 9733235) and 150mm (Product 9733236) sizes used to secure patient references during image-guided surgical procedures. While no injuries have been reported, an improper fit can lead to delays in surgery or the need to use alternative surgical tools.

Risk

If the reference pin does not fit the frame or adapter properly, it could cause delays during computer-assisted surgeries or prevent the rigid attachment needed for accurate surgical navigation.

What You Should Do

  1. This recall affects Medtronic Sterile Percutaneous Reference Pin Sets (100mm and 150mm sizes) used to place pins into bony anatomy for rigid attachment during image-guided surgeries.
  2. Check the product number (9733235 or 9733236) and the lot or serial number printed on your product's sterile packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled devices immediately and quarantine any affected inventory to prevent further use in surgical procedures.
  4. Contact Medtronic Navigation, Inc. or your hospital supply distributor to arrange for the return, replacement, or correction of the affected pins.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and return.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medtronic PIN, 100mm STERILE PERCUTANEOUS
Variants: 100mm
Model / REF:
9733235
Serial Numbers (62):
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
UDI:
00613994247872
GTIN:
00643169105676

Quantity: 67,370 pins across all sizes.

Product: Medtronic PIN, 150MM, STERILE PERCUTANEOUS
Variants: 150mm
Model / REF:
9733236
Serial 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
UDI:
613994247865
GTIN:
643169105669

Reference number in description appears as 97733236 in one text block and 9733236 in code info; 9733236 is used as the primary identifier.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95970
Status: Active
Manufacturer: Medtronic Navigation, Inc.
Sold By: Hospital supply channels; Medtronic direct sales
Manufactured In: United States
Units Affected: 67,370 pins
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.