The Recall Desk

Manufacturer

OrthoPediatrics Corp

26 recalls in our database name OrthoPediatrics Corp as the manufacturing or recalling firm.

What the numbers show

Total
26
Critical
0
Severe
2
Most recent
2023-02-22

Of the 26 recalls from OrthoPediatrics Corp we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 26

  • HighFDA (Devices)·Z-0277-2023·2023-02-22

    Orthopedic Implant Bolts Recalled Due to Breakage Risk in Bone Correction

    OrthoPediatrics has recalled Orthex Large Bone Shoulder Bolts due to breakage risk that may disrupt bone correction and healing. Affected units were distributed in the United States and internationally.

    Product
    Orthex Large Bone Shoulder Bolt, model no. AS-17
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1678-2022·2022-09-14

    External Fixation Wire May Fracture During Surgery, Leaving Fragments in Patient

    OrthoPediatrics Corp is recalling an external fixation wire due to manufacturing variance that may cause the tip to fracture. Fractured fragments could remain in patients.

    Product
    Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2742-2020·2020-08-05

    OrthoPediatrics Recalls Spine Rods Due to Potential Fracture Risk

    OrthoPediatrics Corp is recalling 73 units of 6.0MM spine rods because incorrect laser etching may compromise strength and lead to unintended fracture.

    Product
    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 posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2539-2020·2020-07-15

    OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

    OrthoPediatrics Corp is recalling 11 units of ShieldLoc 7mm implant components because some packages contain the wrong size product.

    Product
    OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2538-2020·2020-07-15

    OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

    OrthoPediatrics Corp is recalling 9 units of ShieldLoc 6mm implant components because some packages contain the wrong size.

    Product
    OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0219-2020·2019-11-06

    OrthoPediatrics Recalls Adolescent Nail Attachment Bolts Due to Binding Risk

    OrthoPediatrics Corp is recalling 969 Adolescent Nail Attachment Bolts because binding between the bolt and nail may delay surgical procedures.

    Product
    Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0218-2020·2019-11-06

    OrthoPediatrics Recalls Child Nail Attachment Bolts Due to Binding Risk

    OrthoPediatrics Corp is recalling 969 Child Nail Attachment Bolts because they may bind with the intramedullary nail, potentially delaying surgical procedures.

    Product
    Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instrume
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2020·2019-10-23

    OrthoPediatrics Recalls Adolescent Attachment Bolts Due to Interference Risk

    OrthoPediatrics Corp is recalling 211 units of Adolescent attachment bolts used with the Pediatric Nailing Platform. The recall is due to potential interference between the bolt and nail, which may delay surgical procedures.

    Product
    OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0597-2018·2018-02-21

    OrthoPediatrics Recalls 7.0mm Pedicle Screws Due to Color Anodizing Error

    OrthoPediatrics Corp is recalling 24 units of 7.0mm x 40mm pedicle screws because they were color anodized with the same color used for 5mm screws.

    Product
    Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2321-2017·2017-06-14

    OrthoPediatrics Recalls Response BandLoc Tensioner Instruments Due to Band Rupture Risk

    OrthoPediatrics Corp is recalling 82 Response BandLoc 5.5/6.0 Tensioner Instruments because over-tensioning can damage the band, causing it to rupture during spine surgery.

    Product
    Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-0879-2017·2016-12-28

    OrthoPediatrics PediNail Cortical Screw Recalled for Dimensional Discrepancy

    OrthoPediatrics is recalling 22 PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screws because they measure 50mm instead of the labeled 48mm.

    Product
    OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2844-2016·2016-09-28

    OrthoPediatrics Recalls Mislabeled 3.5mm Bowed Locking Compression Femur Plates

    OrthoPediatrics Corp is voluntarily recalling 41 units of 3.5mm Bowed Locking Compression Femur Plates due to mislabeling. The devices were distributed nationwide to specific states.

    Product
    3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, Pe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2843-2016·2016-09-28

    OrthoPediatrics Recalls Mislabeled 3.5mm Bowed Locking Compression Femur Plates

    OrthoPediatrics Corp is voluntarily recalling 41 units of 3.5mm Bowed Locking Compression Femur Plates due to mislabeling.

    Product
    3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, Pe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2016·2016-01-20

    OrthoPediatrics Recalls Response Spine Pedicle Screws Due to Manufacturing Defect

    OrthoPediatrics Corp is recalling 102 Response Spine UniAxial Pedicle Screws because they may have been manufactured incorrectly, preventing the driver from fully engaging the screw.

    Product
    UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative d
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2796-2015·2015-09-30

    OrthoPediatrics Recalls 3.5mm Non Locking Cortical Screws Due to Packaging Error

    OrthoPediatrics Corp is recalling 3.5mm Non Locking Cortical Screws because the packaging may contain a different screw size than labeled.

    Product
    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.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2560-2014·2014-09-10

    OrthoPediatrics ACL Sleeve Installation Tool Recalled for Weld Fractures

    OrthoPediatrics Corp is recalling 56 ACL Sleeve Installation Tools due to weld fractures. The tools are used in pediatric and small stature adult ACL reconstruction systems.

    Product
    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 System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0934-2014·2014-02-12

    OrthoPediatrics Recalls 3.5mm Locking Cortical Bone Screws Due to Packaging Error

    OrthoPediatrics is recalling 12 units of 3.5mm Locking Cortical Bone Screws because the packages incorrectly contain non-locking screws.

    Product
    3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0579-2014·2014-01-01

    OrthoPediatrics ACL Sleeve Installation Tool Recall for Incorrect Size Etching

    OrthoPediatrics Corp is recalling 40 ACL Sleeve Installation Tools that may be etched with the wrong size. The tools were shipped in November 2013.

    Product
    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surger
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0276-2014·2013-11-20

    OrthoPediatrics Recalls 3.5mm Locking Screws Due to Packaging Labeling Error

    OrthoPediatrics Corp is recalling 3.5mm locking screws because the packaging description incorrectly identified them as 7.0mm screws, despite the correct part number.

    Product
    3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1941-2013·2013-08-21

    OrthoPediatrics Recalls 2.5mm Drill Bits Due to Packaging Labeling Error

    OrthoPediatrics is voluntarily recalling 68 packaged 2.5mm drill bits because the packaging incorrectly lists the size as 3.2mm.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2013·2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 130 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2013·2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1535-2013·2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Spe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0432-2013·2012-11-28

    OrthoPediatrics Recalls 4.5mm PLEO Osteotomy Guide Instruments

    OrthoPediatrics Corp is recalling 24 units of the 4.5mm PLEO Osteotomy Guide because the device was not manufactured to design specifications and will not function as intended.

    Product
    4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0207-2013·2012-11-14

    OrthoPediatrics Recalls Trochar Scalpel Instruments for Design Defect

    OrthoPediatrics Corp is recalling 78 trochar scalpel instruments that were not manufactured to design specifications and will not function as intended.

    Product
    Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Orthopediatrics

American pediatric company

Founded
2006

Source: Wikidata (Q55641346), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.