Recall Z-1666-2015 ยท IQI Orthosis, Limb Brace
United Surgical Associates
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.
| Date | May 23, 2015 (initiated Apr 13, 2015) |
| Status | Terminated |
| Reason | The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction |
| Root cause | 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 | 756 |
| Distribution | Domestic: HI International; None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.