Home / Recalls / RTI Surgical, Inc. / Z-1441-2017

Z-1441-2017 Class II Terminated

Recalled by RTI Surgical, Inc. — Alachua, FL

Recall Details

Product Type: Devices
Report Date: March 22, 2017
Initiation Date: January 23, 2017
Termination Date: April 5, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24 units

Product Description

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

Reason for Recall

Incorrect instructions for use (IFU) included.

Distribution Pattern

International Distribution: Colombia only

Code Information

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.