Class II — BTE Technologies, Inc.
| Recalling firm | BTE TECHNOLOGIES |
|---|---|
| Registered facility | BTE TECHNOLOGIES (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 510 Devices |
| Distribution | 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. |
| Initiated | 2015-04-09 |
| Classified | 2015-07-06 |
| Terminated | 2016-05-10 |
| Recall number | Z-1986-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BTE Technologies, Inc. (Z-1986-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71443/
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