Device product
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
Z-0203-2016
Product summary
- Event
- Event 72312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-0203-2016
Official wording
Reason: The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
Code information: P/N: 14-521550; Lot Numbers: 463870; P/N: 14-521548; Lot Numbers: J86056; P/N: 14-521518; Lot Numbers: J26394; Model Numbers: 14-521518 14-521520 14-521548 14-521550
Distribution pattern: US Distribution to the states of : NY, MO, and FL
Derived failure modes
-
Unknown
The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.