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RecallWatchMedical Device Safety
Class IIOngoingZ-1022-2025

Medtronic Navigation, Inc. recalls Medtronic PIN

Medtronic Navigation, Inc.Lafayette, CO, United StatesReported Feb 5, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI codeGTIN code
    127 affected lots
    20230711422023080327202308033020230913512023091353202309135420230913552023091356
    +119 more2023100459202310046020231011392023101140202310147020231014722023101473202311036820231103702023110371202311082120231108232023110824202311148920231114902023111491202312000820231200092023120434202312083420231208352023121177202401033020240103322024011153202402101120240210142024021015202402101620240211002024021103202402136520240403272024040895202404089620240506862024050687202405068820240512212024051222202405122520240512262024060262202406047920240604802024060484202407040820240704092024070410202407041120240704142024070415202408052920240805300064316910567620230913512023100459202310114020231014722023101473150mm97332366139942478652023071143202307114420230913572023091358202309135920230913602023101141202310114220231014712023110372202311037320231108222023111492202312001020231200392023120040202312004120231200422023120431202312043220231204332023120831202312083220231211782024010333202401033420240111542024011155202402101220240210132024021101202402110220240213642024021366202402136720240403252024040328202404089720240408982024050689202405122420240602632024060481202406048220240604832024070413202407041620240704172024080534202408053564316910566920230711432023071144202310114220231108222023120010

What the firm is doing

On 12/04/2024, the firm send an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS 2-Day mail to customers to inform them that Medtronic has become aware that certain percutaneous pin lots have been identified as having the potential for an out of round diameter, that may render the percutaneous pin unable to fit into the Patient Reference Frame (9732353) or Percutaneous Pin Adapter (9734752). Customers are instructed to: 1.Immediately locate and quarantine all unused impacted product(s). See Attachment A for affected lot numbers and product identification. 2.Return unused impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form 3.Complete the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information, and email the completed form to Medtronic at neuro.quality@medtronic.com. If the affected devices have already been utilized and/or discarded, we still ask that you complete and return the Customer Confirmation Form detailing that information. 4.This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. Any questions regarding this communication, please contact your Medtronic Sales Representative or Technical Services at 1-888-826-5603.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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