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Recall Observatory FDA recall evidence

Device product

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

Z-0855-2016

December 23, 2015

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 73042
Status
Terminated
Classification
Class II
Quantity
3,741 units
Official record key
device-enforcement:Z-0855-2016

Official wording

Reason: 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.

Code information: All lots of the following Catalog Numbers: 2704-1-024; 2704-3-018; 6703-1-018; 6703-2-120; 6704-1-018; 6704-2-120 and 6704-3-120.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.