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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker XIA 3 TORQUE WRENCH

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 Class 2 Recall
Stryker XIA 3 TORQUE WRENCH
see related information
Date Posted November 19, 2012
Recall Status1 Open
Recall Number Z-0380-2013
Recall Event ID 63386
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
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.
Code Information Class I device, 510(K) exempt Catalog Number: 48237028 Lot Number: 093653, 093654, 093655
Recalling Firm/
Manufacturer
Stryker Spine
2 Pearl Ct
Allendale, New Jersey 07401-1611
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Michelle Barry
201-760-8150
Manufacturer Reason
for Recall
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Quantity in Commerce 54
Distribution Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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