Recall Z-1393-2016— RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Name: FDA recall Z-1393-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-18

Class II · Terminated

Class II FDA medical device recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), initiated 2016-03-18, terminated 2016-09-12. It names one FDA 510(k) clearance: K150254. Product: RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver. Reason: Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use..

Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Classification: Class II
Status: Terminated
Initiated: 2016-03-18
Terminated: 2016-09-12
Firm location: Marquette, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K150254 — Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)·cleared 2015-04-28

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 Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

Reason for recall

Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.

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