Z-1666-2015Class II

Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical...

Name: Z-1666-2015 Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical...
Creator: United Surgical Associates
Published: 2015-04-13
License: https://open.fda.gov/license/

United Surgical LLC / initiated 2015-04-13 / Terminated / root cause: labeling and UDI

FDA source

United Surgical Associates began a recall of 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... on 2015-04-13. FDA classified it as Class II and gives the reason as "The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1666-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-13
Posted: 2015-05-23
Terminated: 2015-07-14
Recalling firm: United Surgical LLC
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.
Product code: IQI Orthosis, Limb Brace
Reason for recall: The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Root cause tag: labeling and UDI
FDA 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 in commerce: 756
Distribution: Domestic: HI International; None
Product codes and lots: Product # i-75100 Lot# AK20140801002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1666-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1664-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1665-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1666-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23

Product code IQI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)