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U.S. Department of Health and Human Services

Class 2 Device Recall Mini MaxTorque HCS05632 Drivers

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  Class 2 Device Recall Mini MaxTorque HCS05632 Drivers see related information
Date Initiated by Firm January 29, 2010
Date Posted October 09, 2012
Recall Status1 Terminated 3 on February 20, 2013
Recall Number Z-0027-2013
Recall Event ID 54725
510(K)Number K082574  
Product Classification Screw, fixation, bone - Product Code HWC
Product OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS

The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Code Information HSC-056-38-1067061
Recalling Firm/
Manufacturer		 Orthohelix Surgical Designs Inc
1065 Medina Rd., Suite 500
Medina OH 44256
For Additional Information Contact
330-869-9582
Manufacturer Reason
for Recall		 The tips of the drivers are breaking while being used to drive the screws into patients.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action The firm, OrthoHelix Surgical Designs, Inc., sent an "IMPORTANT RECALL NOTICE: Mini MaxTorque HCS-056-32 & HCS-056-38 Drivers" dated January 29, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue the use of these drivers immediately and return them to OrthoHelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina, OH 44256; ATTN: Driver Recall. Should you have any questions about system, call 330-247-1145 or the Director of Regulatory Affairs & Quality Assurance at 330-247-1444.
Quantity in Commerce 120 Pieces
Distribution Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.
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.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = ORTHOHELIX SURGICAL DESIGNS, INC.
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