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Stryker Howmedica Osteonics Corp. recalls Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Recalled March 2, 2016 · FDA recall Z-0855-2016 · Stryker Howmedica Osteonics
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. · FDA Class II
Units
3,741 units
Sold at
Nationwide Distribution.
Description
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.
Product
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Manufacturer(s)
Stryker Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →