Reported Feb 26, 2014 · Terminated

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

Implantech Associates Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Implantech Associates Inc · 6025 Nicolle St Ste A · Ventura, CA · 93003-7602

Is this the product you have?

    • Gelzone Shoulder Sleeve
    • Catalog Number SLV634
    • Lot Number 852766
  • Product UsageTo be used where limb support and/or elevation is considered necessary
Lot codes and dates
    • Catalog Number SLV634
    • Lot Number 852766
Amount recalled
300

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 12, 2015 · Data as of Sep 19, 6:07 PM UTC

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