Date Initiated by Firm |
April 01, 2011 |
Date Posted |
September 07, 2011 |
Recall Status1 |
Terminated 3 on March 23, 2012 |
Recall Number |
Z-3162-2011 |
Recall Event ID |
58473 |
510(K)Number |
k092624
|
Product Classification |
Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
|
Product |
Ratcheting 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. |
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 |
Action |
Orthofix, 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 Commerce |
287 units |
Distribution |
Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia and Germany. |
Total Product Life Cycle |
TPLC Device Report
|
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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) Database |
510(K)s with Product Code = NKB and Original Applicant = BLACKSTONE MEDICAL, INC.
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