Primus — Class II medical device recall Z-1986-2015
Terminated recall by BTE Technologies, Inc., reported 2015-07-15, distributed nationwide. On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift B
| Recall number | Z-1986-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BTE Technologies, Inc., Hanover, MD, United States |
| Recall initiated | 2015-04-09 |
| Classified | 2015-07-06 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2016-05-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CN, DE, ES, FR, GB, GR, HK, IN, IT, JP, KR, MX, PL, RO, SA, SG, TH, ZA |
| Quantity | 510 devices |
| Reason classes | device malfunction |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1986-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.