OrthoPediatrics Corp recalls Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon…

Recall date

April 24, 2017

Source

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

Recall number

Z-2321-2017

FDA classification

Class II

Brand / firm

OrthoPediatrics Corp

Sold / distributed

Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.

Why it was recalled

Over-tensioning of the band resulting in damage to the band causing it to rupture

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

What was recalled

Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.