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U.S. Department of Health and Human Services

Class 2 Device Recall Fitness Gear Inversion table

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 Class 2 Device Recall Fitness Gear Inversion tablesee related information
Date Initiated by FirmDecember 29, 2014
Date PostedJanuary 20, 2015
Recall Status1 Terminated 3 on September 02, 2015
Recall NumberZ-1003-2015
Recall Event ID 70136
Product Classification Apparatus, traction, non-powered - Product Code HST
ProductFitness 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.
Code Information Style STE00059FG and Style STE00118FG
Recalling Firm/
Manufacturer		 Dick's Sporting Goods
345 Court St
Coraopolis PA 15108-3817
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionDSG 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 Commerce32581
DistributionNationwide.
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.
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