| Class 2 Device Recall Gelzone Shoulder Sleeve | |
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
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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
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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 |
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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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