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U.S. Department of Health and Human Services

Class 2 Device Recall Primus (THE BTE WS30)

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  Class 2 Device Recall Primus (THE BTE WS30) see related information
Date Initiated by Firm April 09, 2015
Date Posted July 06, 2015
Recall Status1 Terminated 3 on May 10, 2016
Recall Number Z-1986-2015
Recall Event ID 71443
510(K)Number K933611  
Product Classification Exerciser, measuring - Product Code ISD
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.
Code Information Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30)
Recalling Firm/
Manufacturer		 BTE Technologies, Inc.
7455 New Ridge Rd Ste L
Hanover MD 21076-3143
For Additional Information Contact Ewa Kaczanowska
410-850-0333
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ISD and Original Applicant = BALTIMORE THERAPEUTIC EQUIPMENT CO.
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