Recall Z-2321-2017— OrthoPediatrics Corp
Class II · Terminated
Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2017-04-24, terminated 2017-09-18. It names one FDA 510(k) clearance: K161267. 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.. Reason: Over-tensioning of the band resulting in damage to the band causing it to rupture.
- Recalling firm
- OrthoPediatrics Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-24
- Terminated
- 2017-09-18
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.