Z-1428-2022 Class II Terminated
FDA device recall Z-1428-2022 was initiated by Aesculap Implant Systems LLC on July 13, 2020 and is designated Class II. 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. The recall status is terminated (terminated April 26, 2024). Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- July 13, 2020
- Termination Date
- April 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
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.
Distribution Pattern
United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
Code Information
UDI-DI: 04046964719622