Device product
Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.
Z-0828-2016
Product summary
- Firm
- Stryker Spine
- Event
- Event 73180
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31 units
- Official record key
device-enforcement:Z-0828-2016
Official wording
Reason: Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
Code information: Lot #144933, 14D252, and 14D253.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.