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Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Recalled July 27, 2022 · FDA recall Z-1428-2022 · Aesculap Implant Systems
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. · FDA Class II
Units
16
Sold at
United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
Description
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.
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →