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Recall Observatory FDA recall evidence

Device product

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Z-1429-2022

November 18, 2020

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 90526
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-1429-2022

Official wording

Reason: Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.

Code information: UDI-DI: 04046964719622

Distribution pattern: United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.