BTE Technologies, Inc. recalls Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provi…

Recall date

April 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1986-2015

FDA classification

Class II

Brand / firm

BTE Technologies, Inc.

Sold / distributed

Worldwide Distribution - Nationwide Distribution and to the countries of : Austria, Belgium, Canada, France, Germany, Greece, Hong Kong, Italy, India, Japan, South Korea, Mexico, P.R. China, Poland, Republic of South Africa, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand, and United…

Why it was recalled

On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap hook. The snap hook could open, resulting in possible injury to the user due to a fall.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.