FDAFDA · Food and drugs·Recall number Z-1986-2015
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.
Published July 15, 2015 · Recall initiated: April 9, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BTE Technologies, Inc.
- Distributor
- 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 Kingdom.
- Lot
- Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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