Device product
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.
Z-0380-2013
Product summary
- Firm
- Stryker Spine
- Event
- Event 63386
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54
- Official record key
device-enforcement:Z-0380-2013
Official wording
Reason: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Code information: Class I device, 510(K) exempt Catalog Number: 48237028 Lot Number: 093653, 093654, 093655
Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
Derived failure modes
-
Unknown
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.