OrthoPediatrics Corp

Complete recall history across all FDA and CPSC categories — 26 total recalls

OrthoPediatrics Corp appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (26)

FDA medical device enforcement actions by OrthoPediatrics Corp

Date Product Reason Class
Sep 12, 2022 Orthex Large Bone Shoulder Bolt, model no. AS-17 Bolt breakage on the head or threaded portion, which may cause loss of strut ... Class II
Jun 29, 2022 Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN Manufacturing variance near transition of tip is increasing the likelihood th... Class II
Jul 6, 2020 Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 S... Product may have incorrect laser etched alignment lines, the non-conforming ... Class II
Jun 5, 2020 OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component mod... ShieldLoc implant component of the ACL Reconstruction Systemlots may be label... Class II
Jun 5, 2020 OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component mod... ShieldLoc implant component of the ACL Reconstruction Systemlots may be label... Class II
Aug 19, 2019 Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatr... Binding can occur between the attachment bolt and intramedullary nail, which ... Class II
Aug 19, 2019 OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing P... Interference can occur between the adolescent attachment bolt and the adolesc... Class II
Aug 19, 2019 Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pe... Binding can occur between the attachment bolt and intramedullary nail, which ... Class II
Aug 3, 2017 Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage:... The 7mm diameter uniaxial pedicle screws have been color anodized with the sa... Class II
Apr 24, 2017 Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01... Over-tensioning of the band resulting in damage to the band causing it to ru... Class II
Nov 18, 2016 OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical... Labeled as a 48mm Cortical Screw but measuring at 50mm Class III
Jul 27, 2016 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLo... OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowe... Class II
Jul 27, 2016 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLo... OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowe... Class II
Nov 10, 2015 UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5... Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have ... Class II
Jul 28, 2015 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part nu... The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J pac... Class II
Jul 25, 2014 ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9... Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. Class II
Jan 8, 2014 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No.... OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5M... Class II
Nov 7, 2013 OrthoPediatrics ACL Reconstruction System is a pediatric and small stature ad... Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped No... Class II
Sep 26, 2013 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics ... The firm identified, through complaints that the 3.5MM LOCKING SCREW packagin... Class II
Jul 24, 2013 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System ... OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm... Class II
Apr 19, 2013 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage:... Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indic... Class II
Apr 19, 2013 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage:... Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indic... Class II
Apr 19, 2013 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage:... Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indic... Class II
Oct 18, 2012 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, ext... Complaint received from sales representative that the drill guide tubes would... Class II
Sep 13, 2012 Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary... A complaint received from sales representative that a replenishment instrumen... Class II
Jun 14, 2012 OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compressi... The device is a Left 8 hole plate but is incorrectly labeled and etched as a ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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