PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 2, 2016 Initiated: December 18, 2015 #Z-0828-2016

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.

Details

Recalling Firm
Stryker Spine
Units Affected
31 units
Distribution
Nationwide Distribution
Location
Allendale, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Stryker Spine. Units affected: 31 units.
Why was this product recalled?
Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0828-2016.