FDAApril 9, 2015device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

bte technologiesbte

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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