Z-1063-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2014
- Initiation Date
- January 29, 2014
- Termination Date
- March 12, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300
Product Description
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.
Code Information
Catalog Number SLV634, Lot Number 852766.