Device product
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Z-0977-2015
Product summary
- Event
- Event 70065
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 devices
- Official record key
device-enforcement:Z-0977-2015
Official wording
Reason: A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
Code information: Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
Distribution pattern: Nationwide Distribution including TX, OH, VA, and Washington, DC.
Derived failure modes
-
Unknown
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.