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Recall Observatory FDA recall evidence

Device product

Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body

Z-1750-2018

March 23, 2018

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 79792
Status
Terminated
Classification
Class II
Quantity
39 units
Official record key
device-enforcement:Z-1750-2018

Official wording

Reason: Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.

Code information: GTIN/UPN: 643169329218 Lot Number: H5399679

Distribution pattern: Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.