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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Vitallium Wire (6 Pack) Non Sterile

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  Class 2 Device Recall Stryker Vitallium Wire (6 Pack) Non Sterile see related information
Date Initiated by Firm December 23, 2015
Create Date February 23, 2016
Recall Status1 Terminated 3 on May 19, 2017
Recall Number Z-0855-2016
Recall Event ID 73042
510(K)Number K031127  
Product Classification Staple, fixation, bone - Product Code JDR
Product Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
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.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Ms. Aminah Crawford
201-831-5272
Manufacturer 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.
FDA Determined
Cause 2		 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 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 .
Quantity in Commerce 3,741 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JDR and Original Applicant = HOWMEDICA OSTEONICS CORP.
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