Z-0855-2016Class II

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

Name: Z-0855-2016 Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-12-23
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-12-23 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures on 2015-12-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0855-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-23
Posted: 2016-02-23
Terminated: 2017-05-19
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Product code: JDR Staple, Fixation, Bone
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.
Root cause tag: labeling and UDI
FDA 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 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 ([email protected] 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0855-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0855-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-23

Product code JDR

K031127Class IIOrthopedic WireHowmedica Osteonics Corp. / cleared 2003-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)