FDA recall Z-1429-2022

Product

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-11-18

Report date

2022-07-27

Termination date

2024-12-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2022