OrthoPediatrics Corp
18 recalls on record · Latest: Sep 14, 2022
FDA Devices Moderate Sep 14, 2022
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
FDA Devices Moderate Aug 5, 2020
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the pos…
FDA Devices Moderate Jul 15, 2020
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tend…
FDA Devices Moderate Nov 6, 2019
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system c…
FDA Devices Moderate Oct 23, 2019
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system …
FDA Devices Moderate Feb 21, 2018
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
FDA Devices Moderate Jun 14, 2017
Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tens…
FDA Devices Moderate Sep 28, 2016
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both co…
FDA Devices Moderate Sep 28, 2016
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both co…
FDA Devices Moderate Jan 20, 2016
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of th…
FDA Devices Moderate Sep 30, 2015
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 ped…
FDA Devices Moderate Sep 10, 2014
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction S…
FDA Devices Moderate Jan 1, 2014
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , …
FDA Devices Moderate Nov 20, 2013
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one c…
FDA Devices Moderate Aug 21, 2013
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
FDA Devices Moderate Jun 19, 2013
90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intende…
FDA Devices Moderate Jun 19, 2013
90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intende…
FDA Devices Moderate Aug 1, 2012