RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

Recall date

March 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1393-2016

FDA classification

Class II

Brand / firm

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Sold / distributed

Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None

Why it was recalled

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

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