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

FDA device recall Z-1986-2015 · posted 2015-07-06 · Terminated

Recall details

Recalling firm

BTE Technologies, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

ISD

Quantity affected

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, R

Date initiated

2015-04-09

Date posted

2015-07-06

Date terminated

2016-05-10

Location

Hanover, MD

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