Home / Recalls / OrthoPediatrics Corp / Z-2796-2015

Z-2796-2015 Class II Terminated

Recalled by OrthoPediatrics Corp — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
September 30, 2015
Initiation Date
July 28, 2015
Termination Date
March 17, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5

Product Description

3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.

Reason for Recall

The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.

Distribution Pattern

Domestic: TN, IA Foreign: England VA/DOD: None

Code Information

Part number 00-0903-2510, Lot number 150192-J

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-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)