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U.S. Department of Health and Human Services

Class 2 Device Recall MaxTorque Cannulated Screw

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 Class 2 Recall
MaxTorque Cannulated Screw
see related information
Date Posted April 06, 2010
Recall Status1 Terminated on October 20, 2010
Recall Number Z-1250-2010
Recall Event ID 54540
Premarket Notification
510(K) Number
K060428 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product MaxTorque Cannulated Screw Model # MSD-010-55-060S
Code Information Model # MSD-010-55-060S
Recalling Firm/
Manufacturer
Orthohelix Surgical Designs Inc
1065 Medina Rd., Suite 500
Medina, Ohio 44256
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action On April 7, 2009 the firm sent letters to their customers with detailed instructions on how to correct the problem. Pictures were included for clarification. For questions please contact either Jim Bragg via phone at 330-869-9562 ext 211 or Kristin Wolff at ext 209.
Quantity in Commerce 45 pieces
Distribution Product was delivered to: CA, CO, GA, NM, NY, OH, VA & WA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = ORTHOHELIX SURGICAL DESIGNS, INC.
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