Z-2321-2017 Class II Terminated
FDA device recall Z-2321-2017 was initiated by OrthoPediatrics Corp on April 24, 2017 and is designated Class II. Reason for recall: Over-tensioning of the band resulting in damage to the band causing it to rupture The recall status is terminated (terminated September 18, 2017). Affected quantity: 82.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- April 24, 2017
- Termination Date
- September 18, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82
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
Distribution Pattern
Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
Code Information
All lots Product Number: 01-1102-1000