Home / Recalls / OrthoPediatrics Corp / Z-0597-2018

Z-0597-2018 Class II Terminated

Recalled by OrthoPediatrics Corp — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
February 21, 2018
Initiation Date
August 3, 2017
Termination Date
May 8, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide Distribution

Code Information

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

Other recalls by OrthoPediatrics Corp

  • Z-0277-2023 Class II — Orthex Large Bone Shoulder Bolt, model no. AS-17 (September 12, 2022)
  • Z-1678-2022 Class II — Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN (June 29, 2022)
  • Z-2742-2020 Class II — Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spin (July 6, 2020)
  • Z-2539-2020 Class II — OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model (June 5, 2020)
  • Z-2538-2020 Class II — OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model (June 5, 2020)
  • Z-0219-2020 Class II — Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pedia (August 19, 2019)
  • Z-0218-2020 Class II — Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric (August 19, 2019)
  • Z-0125-2020 Class II — OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Plat (August 19, 2019)
  • Z-2321-2017 Class II — Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-11 (April 24, 2017)
  • Z-0879-2017 Class III — OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Sc (November 18, 2016)