Recall Z-0855-2016 ยท JDR Staple, Fixation, Bone
Stryker Howmedica Osteonics Corp.
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
| Date | Dec 23, 2015 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Stryker Branches/Agents were notified of the action via email on December 23, 2015. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated December 23, 2015 were sent to Branches/Agents via UPS on December 28, 2015. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated December 23, 2015 were sent to Hospital Risk Managers and doctors via UPS on 12/23/2015. The notification instructed customers of the related issue with the affected product; how to identify affecte |
| Quantity | 3,741 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031127 | ORTHOPEDIC WIRE Howmedica Osteonics Corp., Apr 28, 2003 |