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FDAJuly 13, 2020device

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

aesculap implant systemsaesculapaesculap implant

UPCs

04046964719622

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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