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Terminated

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.

FDA Recall Z-1666-2015 · Posted 2015-05-23

Recalling FirmUnited Surgical Associates
Recall StatusTerminated
Product CodeIQI
Date Initiated2015-04-13
Date Terminated2015-07-14
Product Quantity756

Reason for Recall

The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Domestic: HI International; None

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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