FDA-Device2016-03-02Class II
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Stryker Howmedica Osteonics Corp.
Hazard
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.
Sold states
Nationwide Distribution.
Affected count
3,741 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0855-2016Don't want to check this manually?
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