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U.S. Department of Health and Human Services

Class 2 Device Recall Ratcheting Torque Limiting Handle

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 Class 2 Device Recall Ratcheting Torque Limiting Handlesee related information
Date Initiated by FirmApril 01, 2011
Date PostedSeptember 07, 2011
Recall Status1 Terminated 3 on March 23, 2012
Recall NumberZ-3162-2011
Recall Event ID 58473
510(K)NumberK092624 
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
ProductRatcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case. Product is intended for use with the Set Screw Driver (52-1061) and Adjustable Counter Torque Wrench (52-1265) to perform the final tightening of set screws in a spinal implant construct.
Code Information All serial numbers.
FEI Number 2183449
Recalling Firm/
Manufacturer		 Orthofix, Inc.
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information Contact
214-937-2272
Manufacturer Reason
for Recall		Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse.
FDA Determined
Cause 2		Device Design
ActionOrthofix, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove the affected product from use. Customers were advised to use the combination of the Ratching R Handle and the Set Screw Driver if they experience problems with the Ratching Torque Limiting Handle. A Tracking and Verification form was attached for customers to complete and return to the Orthofix Inc. Regulatory Affairs Department via fax at 214-937-3322. Contact your Account Services Representative at 888-298-5700 for questions regarding the removal and return of the affected product.
Quantity in Commerce287 units
DistributionWorldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia and Germany.
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.
510(K) Database510(K)s with Product Code = NKB
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