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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Percutaneous Pin

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  Class 2 Device Recall Medtronic Percutaneous Pin see related information
Date Initiated by Firm November 28, 2023
Date Posted January 10, 2024
Recall Status1 Open3, Classified
Recall Number Z-0698-2024
Recall Event ID 93611
510(K)Number K131425  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Code Information UDI: 00613994247872/ Serial Numbers: 2023010549, 2023010551, 2023010840, 2023041134, 2023051137, 2023051138, 2023051139, 2023060368, 2023060369
Recalling Firm/
Manufacturer
Medtronic Navigation, Inc.
200 Medtronic Drive
Lafayette CO 80026
For Additional Information Contact Christine Stewart
720-890-3200
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
Action On December 6, 2023, Medtronic Navigation, Inc. issued a Urgent: Medical Device Recall Notification via: UPS . Medtronic ask consignees to take the following actions: 1. Immediately locate and quarantine all unused impacted product(s). Refer to the affected lot numbers identified in Table 1 below. 2. Return the 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 should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.
Quantity in Commerce 4,235 units
Distribution Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Oman, Portugal, Spain, Switzerland, United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = MEDTRONIC NAVIGATION, INC.
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