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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Stryker MANTIS TORQUE WRENCH		see related information
Date Posted November 19, 2012
Recall Number Z-0381-2013
Product Stryker MANTIS TORQUE WRENCH REF 48287028 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: 48287028 Lot Number: 098400
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
Reason for
Recall		 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.
Quantity in Commerce 19 units
Distribution Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.
 
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