Device product
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
Z-0597-2018
Product summary
- Event
- Event 79067
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-0597-2018
Official wording
Reason: The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Code information: Model number: 00-1300-0740, Lot number: M82791-1
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.