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U.S. Department of Health and Human Services

Class 2 Device Recall Modular Foot System

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 Class 2 Recall
Modular Foot System
see related information
Date Posted June 10, 2010
Recall Status1 Terminated on September 10, 2012
Recall Number Z-1784-2010
Recall Event ID 55256
Premarket Notification
510(K) Number
K073624 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
Code Information Lot Number: 0964081
Recalling Firm/
Manufacturer
Orthohelix Surgical Designs Inc
1065 Medina Rd., Suite 500
Medina, Ohio 44256
Manufacturer Reason
for Recall
On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081.
FDA Determined
Cause 2
TRAINING: Employee Error
Action OrthoHelix Surgical Designs, Inc. issued an "Important Field Correction Notice" dated March 23, 2010 via FedEx overnight. They instructed their customers to inventory their stock for affected product. All affected product will be replaced by the firm. For further information, contact OrthoHelix Surgical Designs, Inc. at 1-330-247-1444.
Quantity in Commerce 62 pieces
Distribution Nationwide Distribution -- AZ, CA, CO, FL, GA, ID, IL, MD, NC, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA and 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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