Recall Z-0855-2016— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-0855-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-23

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2015-12-23, terminated 2017-05-19. It names one FDA 510(k) clearance: K031127. Product: Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.. 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..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-12-23
Terminated: 2017-05-19
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K031127 — ORTHOPEDIC WIREHowmedica Osteonics Corp.·cleared 2003-04-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.