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U.S. Department of Health and Human Services

Class 2 Device Recall Highlow:x

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 Class 2 Device Recall Highlow:xsee related information
Date Initiated by FirmNovember 06, 2008
Date PostedJanuary 05, 2009
Recall Status1 Terminated 3 on February 17, 2011
Recall NumberZ-0651-2009
Recall Event ID 50206
Product Classification chair - Product Code IMS
ProductHigh-low:x frame for the x:panda mechanical chair.
Code Information Article numbers 8911605-02, 8911605-02E, 8911606-02, 8911615-02, 8911615-02E and 8911616-02. Manufactured between 8/24/2007 and 10/3/2008.
FEI Number 1053060
Recalling Firm/
Manufacturer		 Snug Seat Inc
12801 E Independence Blvd
Stallings NC 28105
For Additional Information ContactKirk MacKenzie
704-882-0668
Manufacturer Reason
for Recall		Breakage in the welds was discovered in a section of the chair frame.
FDA Determined
Cause 2		Process control
ActionConsignees were notified by letter dated 11/6/2008. Snug Seat sent a repair kit to their retail dealers on 11/18/2008. The kit includes a safety plate, written and video replacement instructions as well as the tools (allen wrench, crescent wrench and two nuts) necessary to make the safety update. Customers were identified using purchase order numbers, and product serial numbers to enable the dealers to identify the purchaser of the product. Due to HIPPA regulations, purchaser information was not available to Snug Seat, Inc. to contact directly. Written notification will be followed up with a telephone call to each dealer to ensure they have received the retrofit kit. Snug Seat will also insure they understand the importance of the kit and how to properly install and document receipt of the update for their customers.
Quantity in Commerce67 units
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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