Recall Z-1441-2017— RTI Surgical, Inc.

Name: FDA recall Z-1441-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-23

Class II · Terminated

Class II FDA medical device recall by RTI Surgical, Inc., initiated 2017-01-23, terminated 2018-04-05. It names one FDA 510(k) clearance: K043421. Product: RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications. Reason: Incorrect instructions for use (IFU) included..

Recalling firm: RTI Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-01-23
Terminated: 2018-04-05
Firm location: Alachua, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K043421 — OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP ICRegeneration Technologies, Inc.·cleared 2005-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.