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OrthoPediatrics Corp recalls Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeo
Recalled June 14, 2017 · FDA recall Z-2321-2017 · OrthoPediatrics
Hazard
Over-tensioning of the band resulting in damage to the band causing it to rupture · FDA Class II
Units
82
Sold at
Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
Description
Over-tensioning of the band resulting in damage to the band causing it to rupture
Product
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.
Manufacturer(s)
OrthoPediatrics Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →