Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1235-2014Class II

Buzzaround XL scooters'

Golden Technologies, Inc / initiated 2014-01-21 / Terminated / root cause: design

Golden Technologies, Inc. began a recall of Buzzaround XL scooters' Product Usage: mobility on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1235-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Golden Technologies, Inc
Product
Buzzaround XL scooters' Product Usage: mobility
Product code
INI Vehicle, Motorized 3-Wheeled
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.
Root cause tag
design
FDA root cause
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
Product codes and lots
GB 116 and GB146 series, with multiple serial numbers

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1235-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1235-2014Class IITerminatedVoluntary: Firm initiated