Medical device recalls Moderate risk

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

Recall date
January 23, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1441-2017
FDA classification
Class II
Brand / firm
RTI Surgical, Inc.
Sold / distributed
International Distribution: Colombia only

Why it was recalled

Incorrect instructions for use (IFU) included.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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