Z-0698-2024Class II

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

Name: Z-0698-2024 Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Creator: Medtronic Navigation, Inc.
Published: 2023-11-28
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2023-11-28 / Open, Classified / root cause: design

FDA source

Medtronic Navigation, Inc. began a recall of Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS on 2023-11-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0698-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-28
Posted: 2024-01-10
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Product code: OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: 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 [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.
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.
Product codes and lots: UDI: 00613994247872/ Serial Numbers: 2023010549, 2023010551, 2023010840, 2023041134, 2023051137, 2023051138, 2023051139, 2023060368, 2023060369

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0698-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0698-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10
Z-0699-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10

Product code OLO

K131425Class IINavigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc. / cleared 2013-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)