FDA-Device2017-06-14Class II
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.
OrthoPediatrics Corp
Hazard
Over-tensioning of the band resulting in damage to the band causing it to rupture
Sold states
Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
Affected count
82
Manufactured in
2850 Frontier Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2321-2017Don't want to check this manually?
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