Z-1986-2015Class II

Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device...

Name: Z-1986-2015 Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device...
Creator: BTE Technologies, Inc.
Published: 2015-04-09
License: https://open.fda.gov/license/

Bte Technologies / initiated 2015-04-09 / Terminated / root cause: design

FDA source

BTE Technologies, Inc. began a recall of Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance... on 2015-04-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1986-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-09
Posted: 2015-07-06
Terminated: 2016-05-10
Recalling firm: Bte Technologies
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 Exerciser, Measuring
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.
Root cause tag: design
FDA root cause: Device Design
Action: BTE sent an Medical Device Correction letter dated April 10, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. In order to correct this issue, please immediately install the provided retrofit kit according to BTE instructions 751W2519 included in the kit. From this point on, the ring on the Chop / Lift Bar shall not be used to connect the Chop / Lift Bar to the snap hook on the 191 Tool or any other device with a snap hook. Only the Eye part of the Jaw and Eye swivel will be used to connect to the snap hook. Please pass this Medical Device Recall notice to all those who need to be aware of it within the customer organization. Once the correction is completed, notify BTE using the provided Field Correction Confirmation card. We apologize for any inconvenience. Please do not hesitate to call BTE Customer Support at 410-850-0333 if you have any questions or concerns.
Quantity in commerce: 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.
Product codes and lots: Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1986-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1986-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-06

Product code ISD

K933611Class IIThe Bte Ws30Baltimore Therapeutic Equipment Co. / cleared 1994-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)