Device recall
Z-1986-2015: Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring…
FDA device recall · Class II · BTE Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-1986-2015 |
|---|---|
| Recall event | 71443 |
| 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. |
| Product code | ISD |
| Recalling firm | BTE Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2016 |
| 510(k) numbers | K933611 |
| FEI number | 1119903 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database