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Recall Observatory FDA recall evidence

Device product

Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.

Z-1063-2014

January 29, 2014

Class II

Product summary

Firm
Implantech Associates Inc
Event
Event 67446
Status
Terminated
Classification
Class II
Quantity
300
Official record key
device-enforcement:Z-1063-2014

Official wording

Reason: 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.

Code information: Catalog Number SLV634, Lot Number 852766.

Distribution pattern: Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.