Reported Mar 22, 2017 · Terminated

RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic…

RTI Surgical, 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: RTI Surgical, Inc. · 11621 Research Cir · Alachua, FL · 32615-6825

Is this the product you have?

  • RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Lot codes and dates
    • Serial #'s: 30303308
    • 30303321
    • 30303327
    • 30303340
    • 3034313
    • 30304314
    • 30304330
    • 30401686
    • 30401699
    • 30401714
    • 30401721
    • 30401723
    • 30401730
    • 30401732
    • 30401735
    • 3041741
    • 30401746
    • 30401750
    • 30718244
    • 30718441
    • 30718442
    • 30718448
    • and 30718449
Amount recalled
24 units

Why it was recalled

Incorrect instructions for use (IFU) included.

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 Apr 5, 2018 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.