FDAFDA · Food and drugs·Recall number Z-2321-2017
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.
Published June 14, 2017 · Recall initiated: April 24, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Over-tensioning of the band resulting in damage to the band causing it to rupture
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
- Lot
- All lots Product Number: 01-1102-1000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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