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.
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
조치
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.
Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
제품 설명
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.