| Class 2 Device Recall Medtronic Percutaneous Pin |  |
Date Initiated by Firm | November 28, 2023 |
Date Posted | January 10, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0699-2024 |
Recall Event ID |
93611 |
510(K)Number | K131425 |
Product Classification |
Orthopedic stereotaxic instrument - Product Code OLO
|
Product | Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS |
Code Information |
UDI: 00613994247865 and 00643169105669(Japan)/ Serial Numbers: 2023041143, 2023051122, 2023051457, 2023051458, 2023060918, 2023051459, 2022030438, 2023041136, 2023041141 |
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 | 4,224 |
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
|
|
|
|