BTE Technologies, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1986-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 9, 2015

Date Posted: July 15, 2015

Recall Number: Z-1986-2015

Event ID: 71443

Reason for Recall:

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.

Status: Terminated

Product Quantity: 510 Devices

Code Information:

Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated