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Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryke...

FDA Recall #Z-0828-2016 — Class II — December 18, 2015

Recall #Z-0828-2016 Date: December 18, 2015 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

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

Recalling Firm

Stryker Spine — Allendale, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

31 units

Distribution

Nationwide Distribution

Code Information

Lot #144933, 14D252, and 14D253.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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