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Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS recallZ-0698-2024 · Medtronic Navigation, Inc. · initiated Nov 28, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Navigation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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 [email protected]. 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.

Recall details

Recall number
Z-0698-2024
Status
Open, Classified
Initiated by the company
Nov 28, 2023
Posted by the FDA
Jan 10, 2024
Recalling firm
Medtronic Navigation, Inc.
Quantity
4,235 units
Product code
OLO
FDA submissions
K131425
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.

Product description

Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS

Code information (models, lots, serial numbers)

UDI: 00613994247872/ Serial Numbers: 2023010549, 2023010551, 2023010840, 2023041134, 2023051137, 2023051138, 2023051139, 2023060368, 2023060369

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93611).

Sources and updates

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