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

Recall date

November 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1429-2022

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R