FDA-Device2016-04-20Class II

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

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

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

Sold states
Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None
Affected count
N/A
Manufactured in
375 River Park Cir, N/A, Marquette, MI, United States
Products
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1393-2016

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