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Recall Observatory FDA recall evidence

Device product

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

Z-0699-2024

November 28, 2023

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 93611
Status
Ongoing
Classification
Class II
Quantity
4,224
Official record key
device-enforcement:Z-0699-2024

Official wording

Reason: 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.

Code information: UDI: 00613994247865 and 00643169105669(Japan)/ Serial Numbers: 2023041143, 2023051122, 2023051457, 2023051458, 2023060918, 2023051459, 2022030438, 2023041136, 2023041141

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.