Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is Recalled by OrthoPediatrics Corp Due to Over-tensioning of the band resulting in damage to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact OrthoPediatrics Corp directly.
Affected 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.
Quantity: 82
Why Was This Recalled?
Over-tensioning of the band resulting in damage to the band causing it to rupture
Where Was This Sold?
This product was distributed to 6 states: FL, KY, MO, NY, NC, OH
About OrthoPediatrics Corp
OrthoPediatrics Corp has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report