FDA Recall
Terminated
Elastic Knee 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.
Recall: Z-1665-2015
·
Initiated April 13, 2015
Recall
- Recall Number
- Z-1665-2015
- Event Number
- 71256
- Firm
- United Surgical Associates
- FEI Number
- 3003707831
- Product Code
- ITQ
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- April 13, 2015
- Posted
- May 23, 2015
- Terminated
- July 14, 2015
- Address
- 2235 Pennsylvania St, Fort Wayne, IN, 46803-2138
Description
Elastic Knee 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.
Reason
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
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.
Distribution
Domestic: HI International; None
Quantity
1260