Recall StatusTerminated
Date Initiated2015-04-09
Date Terminated2016-05-10
Product Quantity510 Devices
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.
Firm 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.
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.