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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 Navigation, Inc.: Medtronic Percutaneous Pins Recalled for Fitting and Removal Issues

Agency Publication Date: January 10, 2024
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Summary

Medtronic Navigation, Inc. has recalled 8,459 sterile percutaneous pins used in surgical procedures because a manufacturing defect may have resulted in cross-pins that do not fit properly. Affected products include the 100mm Pin (REF 9733235) and the 150mm Pin (REF 9733236). This defect can cause the pin to be unable to fit into the tap cap or become too tight to remove during a procedure. Consumers should contact their healthcare provider or Medtronic to determine if their device is part of this voluntary recall initiated in November 2023.

Risk

If a pin is too tight to remove or fails to fit correctly during surgery, it could lead to surgical delays, increased procedure time, or the need for additional medical intervention to resolve the mechanical fit issue.

What You Should Do

  1. Check your surgical inventory for Medtronic 100mm Percutaneous Pins (REF 9733235) with Serial Numbers: 2023010549, 2023010551, 2023010840, 2023041134, 2023051137, 2023051138, 2023051139, 2023060368, or 2023060369.
  2. Check your surgical inventory for Medtronic 150mm Percutaneous Pins (REF 9733236) with Serial Numbers: 2023041143, 2023051122, 2023051457, 2023051458, 2023060918, 2023051459, 2022030438, 2023041136, or 2023041141.
  3. Identify affected products by verifying UDI codes 00613994247872, 00613994247865, or 00643169105669 on the product packaging.
  4. Contact your healthcare provider or Medtronic Navigation, Inc. at their Lafayette, Colorado facility to receive instructions on how to handle or return the affected sterile pins.
  5. Healthcare professionals should immediately stop using pins from the affected serial number lots and follow the instructions provided in the firm's notification letter.
  6. For further questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Professional consultation and manufacturer guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medtronic Pin, 100mm, STERILE, PERCUTANEOUS
Model / REF:
REF 9733235
Z-0698-2024
UPC Codes:
00613994247872
Lot Numbers:
Serial: 2023010549
Serial: 2023010551
Serial: 2023010840
Serial: 2023041134
Serial: 2023051137
Serial: 2023051138
Serial: 2023051139
Serial: 2023060368
Serial: 2023060369
Product: Medtronic Pin, 150mm, STERILE, PERCUTANEOUS
Model / REF:
REF 9733236
Z-0699-2024
UPC Codes:
00613994247865
00643169105669
Lot Numbers:
Serial: 2023041143
Serial: 2023051122
Serial: 2023051457
Serial: 2023051458
Serial: 2023060918
Serial: 2023051459
Serial: 2022030438
Serial: 2023041136
Serial: 2023041141

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93611
Status: Active
Manufacturer: Medtronic Navigation, Inc.
Sold By: Medtronic Navigation, Inc.; Hospital supply distributors
Manufactured In: United States
Units Affected: 2 products (4,235 units; 4,224)
Distributed To: Alaska, Alabama, Arizona, California

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.