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U.S. Department of Health and Human Services

Class 2 Device Recall Golden Buzzaround XL

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 Class 2 Device Recall Golden Buzzaround XLsee related information
Date Initiated by FirmJanuary 21, 2014
Date PostedMarch 20, 2014
Recall Status1 Terminated 3 on July 23, 2015
Recall NumberZ-1235-2014
Recall Event ID 67416
510(K)NumberK041025 
Product Classification Vehicle, motorized 3-wheeled - Product Code INI
ProductBuzzaround XL scooters' Product Usage: mobility
Code Information GB 116 and GB146 series, with multiple serial numbers
FEI Number 2523955
Recalling Firm/
Manufacturer		 Golden Technologies, Inc.
401 Bridge St
Old Forge PA 18518-2323
For Additional Information ContactCustomer Support
800-624-6374
Manufacturer Reason
for Recall		Buzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear alignment screw.
FDA Determined
Cause 2		Device Design
ActionGolden Technologies sent a recall notification letter, dated January 14, 2014 to providers/dealers. A second letter, dated January 21, 2014 was sent to these same customers. Based on a slow initial response, the firm intends to send out the correction kit with the inspection acknowledgement form as soon as possible. Based on the overall response from dealers, a third consumer letter was drafted (notification3) for mailing directly to known consumers, if necessary. For help contact a special technical service hotline at 1-800-624-6374 ext. 392.
Quantity in Commerce5044
DistributionWorldwide Distribution - USA Nationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = INI
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