Events

Recall of Stryker XIA 3 TORQUE WRENCH

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Spine.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63386
  • Event Risk Class
    Class 2
  • Event Number
    Z-0380-2013
  • Event Initiated Date
    2012-08-09
  • Event Date Posted
    2012-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113648
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
  • Action
    Stryker Spine sent an Urgent Medical Device Removal Notification letter/Product Accountability Forms dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For questions regarding this recall call 201-760-8150.

Device

Stryker XIA 3 TORQUE WRENCH
  • Model / Serial
    Class I device, 510(K) exempt  Catalog Number: 48237028 Lot Number: 093653, 093654, 093655
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
  • Product Description
    Stryker XIA 3 TORQUE WRENCH || REF 48237028 || Manufactured by: || Stryker pine SAS || Z.I MARTICOT-33610-CESTAS-FRANCE || +33 (0)5.57.97.06.30 || http://www.stryker.com || Distributed in the USA by: || Stryker Spine, || 2 Pearl Ct. Allendale || NJ 07401-1677 USA || +1-201-780-8000 || The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Manufacturer Address
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA