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U.S. Department of Health and Human Services

Class 2 Device Recall Modified 5.5 mm Modified Depth Gauge for MaxTorque Screw System

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  Class 2 Device Recall Modified 5.5 mm Modified Depth Gauge for MaxTorque Screw System see related information
Date Initiated by Firm October 15, 2010
Date Posted November 26, 2010
Recall Status1 Terminated 3 on September 06, 2012
Recall Number Z-0467-2011
Recall Event ID 57095
510(K)Number K060428  
Product Classification Tap, bone - Product Code HWX
Product CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021
Code Information CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021
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 print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This
FDA Determined
Cause 2		 Device Design
Action OrthoHelix issued an Important Recall Notice letter dated October 15, 2010 to their customers, identifying the affected products. Customers were requested to immediately return the afected devices. OrthoHelix can be contacted at 330 247-1444 concerning this recall.
Distribution Nationwide distribution: to the states of GA and MO.
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 = HWX and Original Applicant = ORTHOHELIX SURGICAL DESIGNS, INC.
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