Home / Recalls / OrthoPediatrics Corp / Z-0879-2017

Z-0879-2017 Class III Terminated

Recalled by OrthoPediatrics Corp — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
December 28, 2016
Initiation Date
November 18, 2016
Termination Date
July 27, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22 units

Product Description

OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw

Reason for Recall

Labeled as a 48mm Cortical Screw but measuring at 50mm

Distribution Pattern

Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.

Code Information

Product Number: 10-1500-3048 Lot Number: 161421-G

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  • 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-0218-2020 Class II — Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric (August 19, 2019)
  • Z-0219-2020 Class II — Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pedia (August 19, 2019)
  • Z-0125-2020 Class II — OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Plat (August 19, 2019)
  • Z-0597-2018 Class II — Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: P (August 3, 2017)
  • Z-2321-2017 Class II — Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-11 (April 24, 2017)