The Recall Desk
HighFDA (Devices)·Z-1986-2015·Announced 2015-07-15

BTE Technologies Recalls Primus Exercise Devices Due to Detachment Risk

BTE Technologies is recalling 510 Primus rehabilitation devices because the optional Chop / Lift Bar may detach, posing a fall hazard to users.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (fall injury) where no specific injuries have been reported yet, fitting the criteria for a High severity score.

Plain-English summary

BTE Technologies, Inc. is recalling 510 units of the Primus (THE BTE WS30) measuring exercise equipment, specifically models PrimusRS (PRRS) and Primus+ (PR30). The recall applies to devices that include the optional Chop / Lift Bar. These devices are designed to provide active and passive torque resistance to patient motion during rehabilitation therapy.

The recall is due to a remote possibility that the Chop / Lift Bar could accidentally detach from the snap hook in specific use scenarios where the bar is rotated and twisted. If the snap hook opens, the bar could fall, resulting in possible injury to the user.

The affected devices were distributed worldwide, including in the United States and numerous international markets such as Canada, the United Kingdom, Germany, and Japan. Consumers and healthcare facilities should stop using the affected devices and contact BTE Technologies for instructions on the recall.

The recalled product

Product
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.
Affected units
510

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.