—#204965

Product

Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS

FDA product code: OLO — Orthopedic Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K131425
Affected lot / code info: UDI: 00613994247865 and 00643169105669(Japan)/ Serial Numbers: 2023041143, 2023051122, 2023051457, 2023051458, 2023060918, 2023051459, 2022030438, 2023041136, 2023041141

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 200 Medtronic Drive, Lafayette, Colorado 80026

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-11-28
Posted by FDA: 2024-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204965. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.