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Recall Observatory FDA recall evidence

Device product

Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.

Z-0574-2014

November 20, 2013

Class II

Product summary

Firm
SpineFrontier, Inc.
Event
Event 66914
Status
Terminated
Classification
Class II
Quantity
922
Official record key
device-enforcement:Z-0574-2014

Official wording

Reason: Mismarked and unmarked screws

Code information: Lot/Serial Number: IM71 059-01: Lot 0000 lM71059-02; IM71059-02: Lot 035M

Distribution pattern: Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Mismarked and unmarked screws