Stryker Vitallium Wire Non Sterile recalled over sterility concerns

Recall date

December 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Howmedica Osteonics Corp. recalls Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.

Recall number

Z-0855-2016

FDA classification

Class II

Brand / firm

Stryker Howmedica Osteonics Corp.

Sold / distributed

Nationwide Distribution.

Why it was recalled

The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized. Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.