RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.

Recall date

April 22, 2016

Source

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

Recall number

Z-1829-2016

FDA classification

Class II

Brand / firm

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

Sold / distributed

US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.

Why it was recalled

Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.