Device product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Z-1429-2022
Product summary
- Event
- Event 90526
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17
- Official record key
device-enforcement:Z-1429-2022
Official wording
Reason: 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.
Code information: UDI-DI: 04046964719622
Distribution pattern: United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.
Derived failure modes
-
Unknown
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.