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Recall Observatory FDA recall evidence

Device product

VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

Z-1941-2020

March 26, 2020

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 85414
Status
Terminated
Classification
Class II
Quantity
83 units.
Official record key
device-enforcement:Z-1941-2020

Official wording

Reason: Nonconforming product; length of the product measured shorter than the labeled length.

Code information: Product no. 6958838. UDI: 00613994354686.

Distribution pattern: US Nationwide distribution in the states of CA and MI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Nonconforming product; length of the product measured shorter than the labeled length.