Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1003-2015Class II

Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on...

Dicks Sporting Goods Inc / initiated 2014-12-29 / Terminated / root cause: labeling and UDI

Dick's Sporting Goods began a recall of Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user... on . FDA classified it as Class II and gives the reason as "Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Table is a fitness product, not a medical device. DSG removed medical claims from product labels and advertising". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1003-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Dicks Sporting Goods Inc
Product
Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.
Product code
HST Apparatus, Traction, Non-Powered
Reason for recall
Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Table is a fitness product, not a medical device. DSG removed medical claims from product labels and advertising.
Root cause tag
labeling and UDI
FDA root cause
Labeling False and Misleading
Action
DSG sent emails and medical device correction notices, dated December 2014, to consumers who made purchases online and retail store consumers for whom DSG has contact information via its Scorecard customer loyalty program. DSG also posted the recall on their web site and notified their retail stores with instructions to post notices in DICKs stores. DSG plans to remind stores approximately monthly for three months to display the recall poster, beginning one month after the recall announcement. Consumers were asked to return the product to the stores where they were purchased for a full refund. A Press Release, dated January 8, 2015, was also issued about the recall.
Quantity in commerce
32581
Distribution
Nationwide.
Product codes and lots
Style STE00059FG and Style STE00118FG

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1003-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1003-2015Class IITerminatedVoluntary: Firm initiated