FDA-Device2022-07-27Class II
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Aesculap Implant Systems LLC
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. Redesign of removal key.
Sold states
United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.
Affected count
17
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2022Don't want to check this manually?
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