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.
Reported: June 14, 2017 Initiated: April 24, 2017 #Z-2321-2017
Product Description
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.
Reason for Recall
Over-tensioning of the band resulting in damage to the band causing it to rupture
Details
- Recalling Firm
- OrthoPediatrics Corp
- Units Affected
- 82
- Distribution
- Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
- Location
- Warsaw, IN
Frequently Asked Questions
What product 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.. Recalled by OrthoPediatrics Corp. Units affected: 82.
Why was this product recalled? ▼
Over-tensioning of the band resulting in damage to the band causing it to rupture
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2321-2017.
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