FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1666-2015
- Recalling firm
- United Surgical Associates
- 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.
- Status
- Terminated
- Initiated
- 2015-04-13
- Posted
- 2015-05-23
- Terminated
- 2015-07-14
- 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
- Lot, serial or model codes
- Product # i-75100 Lot# AK20140801002
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IQI
- Firm FEI
- 3003707831
- Firm city
- Fort Wayne
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28