Events

Recall of Primus (THE BTE WS30)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BTE Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71443
  • Event Risk Class
    Class 2
  • Event Number
    Z-1986-2015
  • Event Initiated Date
    2015-04-09
  • Event Date Posted
    2015-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137821
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Exerciser, measuring - Product Code ISD
  • 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.
  • 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.

Device

Primus (THE BTE WS30)
  • Model / Serial
    Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30)
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 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.
  • Manufacturer
    BTE Technologies, Inc.

Manufacturer

BTE Technologies, Inc.
  • Manufacturer Address
    BTE Technologies, Inc., 7455 New Ridge Rd Ste L, Hanover MD 21076-3143
  • Manufacturer Parent Company (2017)
    BTE Technologies
  • Source
    USFDA