Date Initiated by Firm |
January 21, 2014 |
Date Posted |
March 20, 2014 |
Recall Status1 |
Terminated 3 on July 23, 2015 |
Recall Number |
Z-1235-2014 |
Recall Event ID |
67416 |
510(K)Number |
K041025
|
Product Classification |
Vehicle, motorized 3-wheeled - Product Code INI
|
Product |
Buzzaround XL scooters'
Product Usage: mobility |
Code Information |
GB 116 and GB146 series, with multiple serial numbers |
Recalling Firm/ Manufacturer |
Golden Technologies, Inc. 401 Bridge St Old Forge PA 18518-2323
|
For Additional Information Contact |
Customer 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 |
Action |
Golden 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 Commerce |
5044 |
Distribution |
Worldwide Distribution - USA Nationwide |
Total Product Life Cycle |
TPLC Device Report
|
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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 = INI and Original Applicant = GOLDEN TECHNOLOGIES, INC.
|