Z-1447-2014Class II

K-Lite Knee 2 Stays with Visco, Model No. 122015

Name: Z-1447-2014 K-Lite Knee 2 Stays with Visco, Model No. 122015
Creator: Breg Inc
Published: 2014-03-14
License: https://open.fda.gov/license/

Breg Inc / initiated 2014-03-14 / Terminated / root cause: labeling and UDI

FDA source

Breg Inc began a recall of K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support on 2014-03-14. FDA classified it as Class II and gives the reason as "Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label". 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-1447-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-14
Posted: 2014-04-10
Terminated: 2014-04-14
Recalling firm: Breg Inc
Product: K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.
Product code: IQI Orthosis, Limb Brace
Reason for recall: Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: Breg representatives informed customers of the recall by telephone on March 14, 2014 and then a customer notification letter was sent to customers via email onMarch 17, 2014. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the return response form. Customers with questions are instructed to contact Breg Customer Care at (800) 321-0607.
Quantity in commerce: 2 units
Distribution: USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.
Product codes and lots: Lot No. 705593

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1447-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1446-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-10
Z-1447-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-10

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)