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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker MANTIS TORQUE WRENCH

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  Class 2 Device Recall Stryker MANTIS TORQUE WRENCH see related information
Date Initiated by Firm August 09, 2012
Date Posted November 19, 2012
Recall Status1 Terminated 3 on September 30, 2015
Recall Number Z-0381-2013
Recall Event ID 63386
Product Classification Orthopedic manual surgical instrument - Product Code LXH
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 NJ 07401-1611
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		 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 19 units
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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