FDA-Device2016-03-02Class II

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.

Stryker Spine
Hazard

Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.

Sold states
Nationwide Distribution
Affected count
31 units
Manufactured in
2 Pearl Ct, N/A, Allendale, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0828-2016

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