OrthoPediatrics Corp: Medical Device Recall in 2018 - (Recall #: Z-0597-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation

Product Classification:

Class II

Date Initiated: August 3, 2017

Date Posted: February 21, 2018

Recall Number: Z-0597-2018

Event ID: 79067

Reason for Recall:

The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.

Status: Terminated

Product Quantity: 24 units

Code Information:

Model number: 00-1300-0740, Lot number: M82791-1

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated