OrthoPediatrics Corp recalls

15 recalls on record · latest: September 12, 2022

Official U.S. recall history for OrthoPediatrics Corp, compiled from official government records.

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OrthoPediatrics Corp recalls Orthex Large Bone Shoulder Bolt, model no. AS-17

September 12, 2022 · Medical device recalls Moderate risk Bolt breakage on the head or threaded portion, which may cause loss of strut co…

OrthoPediatrics Corp recalls Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN

June 29, 2022 · Medical device recalls Moderate risk Manufacturing variance near transition of tip is increasing the likelihood the…

OrthoPediatrics Corp recalls Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization…

July 6, 2020 · Medical device recalls Moderate risk Product may have incorrect laser etched alignment lines, the non-conforming las…

OrthoPediatrics Corp recalls OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is…

June 5, 2020 · Medical device recalls Moderate risk ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled…

OrthoPediatrics Corp recalls OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is…

June 5, 2020 · Medical device recalls Moderate risk ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled…

OrthoPediatrics Corp recalls OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an…

August 19, 2019 · Medical device recalls Moderate risk Interference can occur between the adolescent attachment bolt and the adolescen…

OrthoPediatrics Corp recalls Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: a…

August 19, 2019 · Medical device recalls Moderate risk Binding can occur between the attachment bolt and intramedullary nail, which ma…

OrthoPediatrics Corp recalls Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an ort…

August 19, 2019 · Medical device recalls Moderate risk Binding can occur between the attachment bolt and intramedullary nail, which ma…

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

August 3, 2017 · Medical device recalls Moderate risk The 7mm diameter uniaxial pedicle screws have been color anodized with the same…

OrthoPediatrics Corp recalls Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon…

April 24, 2017 · Medical device recalls Moderate risk Over-tensioning of the band resulting in damage to the band causing it to ruptu…

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

November 18, 2016 · Medical device recalls Labeled as a 48mm Cortical Screw but measuring at 50mm

OrthoPediatrics product recalled over labeling errors

July 27, 2016 · Medical device recalls Moderate risk OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed…

OrthoPediatrics product recalled over labeling errors

July 27, 2016 · Medical device recalls Moderate risk OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed…

OrthoPediatrics Corp recalls UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilizat…

November 10, 2015 · Medical device recalls Moderate risk Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have be…

OrthoPediatrics Corp recalls 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking…

July 28, 2015 · Medical device recalls Moderate risk The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J packa…