Date Initiated by Firm | April 13, 2015 |
Date Posted | May 23, 2015 |
Recall Status1 |
Terminated 3 on July 14, 2015 |
Recall Number | Z-1666-2015 |
Recall Event ID |
71256 |
Product Classification |
Orthosis, limb brace - Product Code IQI
|
Product | Keo Brace, elastic wrist brace for carpal tunnel.
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-75100 Lot# AK20140801002 |
Recalling Firm/ Manufacturer |
United Surgical Associates 2235 Pennsylvania St Fort Wayne IN 46803-2138
|
For Additional Information Contact | Andy Opliger 855-332-2446 |
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 | 756 |
Distribution | Domestic: HI
International; None |
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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