OrthoPediatrics Corp: Medical Device Recall in 2017 - (Recall #: Z-2321-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 24, 2017

Date Posted: June 14, 2017

Recall Number: Z-2321-2017

Event ID: 77270

Reason for Recall:

Over-tensioning of the band resulting in damage to the band causing it to rupture

Status: Terminated

Product Quantity: 82

Code Information:

All lots Product Number: 01-1102-1000

Distribution Pattern:

Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.

Voluntary or Mandated:

Voluntary: Firm initiated