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U.S. Department of Health and Human Services

Class 2 Device Recall Specialty Audible Torque Wrench for the Xia 3 Spinal System

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 Class 2 Device Recall Specialty Audible Torque Wrench for the Xia 3 Spinal Systemsee related information
Date Initiated by FirmOctober 06, 2014
Date PostedDecember 16, 2014
Recall Status1 Terminated 3 on May 08, 2017
Recall NumberZ-0803-2015
Recall Event ID 69784
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductSpecialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
Code Information Lot number 4279
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information ContactMr.Linford Leitch
201-760-8041
Manufacturer Reason
for Recall		Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionStryker Spine sent an Urgent Medical Device Removal Notification/Acknowledgement Form dated 10/6/2014 via Fed Ex. The letter identified the affected product, discussed the product description, product issue, potential hazards, risk mitigations, and actions needed. Customers were asked to read the notice thoroughly and make sure that it is understood. Additionally, they are to complete the enclosed acknowledgement form and fax or e-mail it back.
Quantity in Commerce15 units
DistributionDistributed to GA, IN, MI, NJ, OH, PA, TX & VA.
Total Product Life CycleTPLC 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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