Class 1 Device Recall Shoulder Flex Massage Device

• Date Initiated by Firm: August 30, 2011
• Date Posted: November 10, 2011
• Recall Status: Terminated on March 06, 2014
• Recall Number: Z-0172-2012
• Recall Event ID: 59829
• Product Classification: Massager, therapeutic, electric - Product Code ISA
• Product: Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all instructions before using the massager* **WARNING NEVER wear a necklace or similar items while using this product Made in China." Personal use massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while user lies on a flat surface.
• Code Information: Model # SH61
• Recalling Firm/ Manufacturer: King International; 16286 Sw Horseshoe Way; Beaverton OR 97007
• For Additional Information Contact: Bruce C. Hamlin; 503-224-3113
• Manufacturer Reason for Recall: The covered rotating mechanism can catch on user's clothing, jewelry (e.g. necklace), and hair. There have been reports of one death and a strangulation associated with using the device.
• FDA Determined Cause: Component design/selection
• Action: An Urgent Product Recall letter was sent via regular mail to customers. The letter identified the affected product and described the reason for the recall. Customers were asked to stop using Shoulderflex massagers immediately and to safely dispose of them in the trash. The device components should be disposed of separately so that the device cannot be reassembled and used. This means that the power supply should be separated from the massager unit, and the massage fingers should also be removed and disposed of separately. Customers are to complete and return the enclosed the postage-paid card to King International in order to confirm receipt of the recall letter. If additional information is needed regarding this recall, customers are to contact King International LLC at 503-524-7046 or visit their website at www.shoulderflex.com or via mail to PO Box 2384, Beaverton, Oregon 97075. On 8/25/2011 FDA published a health alert on the FDA website. On 8/31/2011 the firm issued a nationwide press release.
• Quantity in Commerce: 11934
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC 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.