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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