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Class 2 Device Recall Modular Foot System |
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Date Initiated by Firm |
March 23, 2010 |
Date Posted |
June 10, 2010 |
Recall Status1 |
Terminated 3 on September 10, 2012 |
Recall Number |
Z-1784-2010 |
Recall Event ID |
55256 |
510(K)Number |
K073624
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Product Classification |
Screw, fixation, bone - Product Code HWC
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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 OH 44256
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For Additional Information Contact |
330-869-9582
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = HWC and Original Applicant = ORTHOHELIX SURGICAL DESIGNS, INC.
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