FDA-Device2014-02-26Class II
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
Implantech Associates Inc
Hazard
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.
Sold states
Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.
Affected count
300
Manufactured in
6025 Nicolle St Ste A, Ventura, CA, United States
Products
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1063-2014Don't want to check this manually?
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