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Recall Observatory FDA recall evidence

Device product

Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.

Z-0321-2016

October 21, 2015

Class II

Product summary

Firm
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Event
Event 72541
Status
Terminated
Classification
Class II
Quantity
9 pieces
Official record key
device-enforcement:Z-0321-2016

Official wording

Reason: The wire pass hole is not present on the tools.

Code information: Catalog Number: 16TA24, Lot Number: 0006936810

Distribution pattern: Distributed in the states of California, New York, and Texas and the country of Belgium.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The wire pass hole is not present on the tools.