Z-1986-2015 Class II Terminated
FDA device recall Z-1986-2015 was initiated by BTE Technologies, Inc. on April 9, 2015 and is designated Class II. 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… The recall status is terminated (terminated May 10, 2016). Affected quantity: 510 Devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2015
- Initiation Date
- April 9, 2015
- Termination Date
- May 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 510 Devices
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.
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.
Code Information
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30)