Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Ster

FDA device recall Z-1022-2025 · posted 2025-01-27 · Open, Classified

Recall details

Recalling firm

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OLO

Quantity affected

67,370 pins

Distribution

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,

Date initiated

2024-12-04

Date posted

2025-01-27

Location

Lafayette, CO

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