medical Class II Updated 2022-07-27

Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Recalled Product

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04046964719622
View official government recall

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