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Recall Observatory FDA recall evidence

Device product

NavLock Tracker *** Rx Only

Z-1693-2020

August 28, 2019

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 85318
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1693-2020

Official wording

Reason: Product was incorrectly assembled which could affect navigation accuracy of the device.

Code information: Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585

Distribution pattern: U.S.: NY No O.U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was incorrectly assembled which could affect navigation accuracy of the device.