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OrthoPediatrics Recalls
26 recalls on record · August 1, 2012 to February 22, 2023 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 22, 2023Medical DevicesFDA
OrthoPediatrics Corp recalls Orthex Large Bone Shoulder Bolt, model no. AS-17
Hazard: Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
September 14, 2022Medical DevicesFDA
OrthoPediatrics Corp recalls Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Hazard: Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
August 5, 2020Medical DevicesFDA
OrthoPediatrics Corp recalls Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization
Hazard: Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
July 15, 2020Medical DevicesFDA
OrthoPediatrics Corp recalls OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is
Hazard: ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
July 15, 2020Medical DevicesFDA
OrthoPediatrics Corp recalls OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is
Hazard: ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
November 6, 2019Medical DevicesFDA
OrthoPediatrics Corp recalls Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: a
Hazard: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
November 6, 2019Medical DevicesFDA
OrthoPediatrics Corp recalls Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orth
Hazard: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
October 23, 2019Medical DevicesFDA
OrthoPediatrics Corp recalls OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an
Hazard: Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
February 21, 2018Medical DevicesFDA
OrthoPediatrics Corp recalls Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixa
Hazard: The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
June 14, 2017Medical DevicesFDA
OrthoPediatrics Corp recalls Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeo
Hazard: Over-tensioning of the band resulting in damage to the band causing it to rupture
December 28, 2016Medical DevicesFDA
OrthoPediatrics Corp recalls OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Hazard: Labeled as a 48mm Cortical Screw but measuring at 50mm
September 28, 2016Medical DevicesFDA
OrthoPediatrics Corp recalls 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that o
Hazard: OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
September 28, 2016Medical DevicesFDA
OrthoPediatrics Corp recalls 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that o
Hazard: OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
January 20, 2016Medical DevicesFDA
OrthoPediatrics Corp recalls UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobiliz
Hazard: Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.
September 30, 2015Medical DevicesFDA
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
Hazard: The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
September 10, 2014Medical DevicesFDA
OrthoPediatrics Corp recalls ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPe
Hazard: Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
February 12, 2014Medical DevicesFDA
OrthoPediatrics Corp recalls 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" T
Hazard: OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.
January 1, 2014Medical DevicesFDA
OrthoPediatrics Corp recalls OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sl
Hazard: Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
November 20, 2013Medical DevicesFDA
OrthoPediatrics Corp recalls 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines impl
Hazard: The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
August 21, 2013Medical DevicesFDA
OrthoPediatrics Corp recalls 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior
Hazard: OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
June 19, 2013Medical DevicesFDA
OrthoPediatrics Corp recalls 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated
Hazard: Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
June 19, 2013Medical DevicesFDA
OrthoPediatrics Corp recalls 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated
Hazard: Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
June 19, 2013Medical DevicesFDA
OrthoPediatrics Corp recalls 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated
Hazard: Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
November 28, 2012Medical DevicesFDA
OrthoPediatrics Corp recalls 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This sy
Hazard: Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
November 14, 2012Medical DevicesFDA
OrthoPediatrics Corp recalls Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devi
Hazard: A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
August 1, 2012Medical DevicesFDA
OrthoPediatrics Corp recalls OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pe
Hazard: The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.