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U.S. Department of Health and Human Services

Class 2 Device Recall Gelzone Shoulder Sleeve

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  Class 2 Device Recall Gelzone Shoulder Sleeve see related information
Date Initiated by Firm January 29, 2014
Date Posted February 20, 2014
Recall Status1 Terminated 3 on March 12, 2015
Recall Number Z-1063-2014
Recall Event ID 67446
Product Classification Apparatus, traction, non-powered - Product Code HST
Product Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766.

Product Usage:
To be used where limb support and/or elevation is considered necessary.
Code Information Catalog Number SLV634, Lot Number 852766.
Recalling Firm/
Manufacturer		 Implantech Associates Inc
6025 Nicolle St Ste A
Ventura CA 93003-7602
For Additional Information Contact
805-339-9415
Manufacturer Reason
for Recall		 Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Implantech sent a Recall Notification letters dated January 29, 2014 via mail and fax to the affected customers. The recall notification letter informed customers of the voluntary recall, product description with code information, reason for recall, contact information, and actions to be taken. The letter also contains a response section to be completed and returned via fax. For questions call 1-800-733-0833 x235.
Quantity in Commerce 300
Distribution Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.
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.
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