Recall Z-1986-2015— BTE Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by BTE Technologies, Inc., initiated 2015-04-09, terminated 2016-05-10. It names one FDA 510(k) clearance: K933611. 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.. 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..
- Recalling firm
- BTE Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-09
- Terminated
- 2016-05-10
- Firm location
- Hanover, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.