Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
FDA Recall #Z-0855-2016 — Class II — December 23, 2015
Product Description
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Reason for Recall
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.
Recalling Firm
Stryker Howmedica Osteonics Corp. — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,741 units
Distribution
Nationwide Distribution.
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated