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U.S. Department of Health and Human Services

Class 2 Device Recall iGO

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  Class 2 Device Recall iGO see related information
Date Initiated by Firm April 13, 2015
Date Posted May 23, 2015
Recall Status1 Terminated 3 on July 14, 2015
Recall Number Z-1664-2015
Recall Event ID 71256
Product Classification Joint, ankle, external brace - Product Code ITW
Product Elastic Ankle Support.

A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
Code Information Product #: i-94103 Elastic Ankle Support SM Lot#: AP20140815001 Product #: i-94105 Elastic Ankle Support MD Lot#: AP20140815001 Product #: i-94107 Elastic Ankle Support LG Lot#: AP20140815001 
Recalling Firm/
United Surgical Associates
2235 Pennsylvania St
Fort Wayne IN 46803-2138
For Additional Information Contact Andy Opliger
Manufacturer Reason
for Recall
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
FDA Determined
Cause 2
Error in labeling
Action On 4/13/2015 United Ortho emailed the affected distributor regarding the need for correction due to latex in the product and that updated labeling and instructions would be provided. United-Ortho personnel will travel to Hawaii and accompany the distributor to label the product at the sites to which it was distributed. Records will be maintained at each location.
Quantity in Commerce 1278
Distribution Domestic: HI International; None
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.