Z-1666-2015 Class II Terminated
FDA device recall Z-1666-2015 was initiated by United Surgical Associates on April 13, 2015 and is designated Class II. Reason for recall: The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction The recall status is terminated (terminated July 14, 2015). Affected quantity: 756.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2015
- Initiation Date
- April 13, 2015
- Termination Date
- July 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 756
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
Distribution Pattern
Domestic: HI International; None
Code Information
Product # i-75100 Lot# AK20140801002