Recall Z-1666-2015— United Surgical Associates
Class II · Terminated
Class II FDA medical device recall by United Surgical Associates, initiated 2015-04-13, terminated 2015-07-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction.
- Recalling firm
- United Surgical Associates
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-13
- Terminated
- 2015-07-14
- Firm location
- Fort Wayne, IN, United States
Product description
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.
Reason for recall
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Data sourced from openFDA. This site is unofficial and independent of the FDA.