Device Recall Stryker Vitallium Wire (6 Pack) Non Sterile 의 리콜

Recall

73042

Class 2

Z-0855-2016

2015-12-23

Terminated

United States

2017-05-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142877

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.

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 affected product; the potential hazards associated with affected product; risk mitigations; and actions needed to be taken. Customers were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerOrtho7808@stericycle.com or Fax (1-866-672-0627 ) the response form back. Customers were instructed to return all affected products to Stryker C/O Stericycle, 2670 Executive Drive, Suite A, Indianapolis, IN 46241 (Attn RA2015-120-Event 7808). A point of contact was provided in case the customer had any questions 201.831.5272 .