Orthopediatrics recalls
Orthopediatrics appears in 26 official U.S. recall notices indexed by RecallRadar, most recently on 2023-02-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 26 |
|---|---|
| Published | 2012-08-01 to 2023-02-22 |
| By agency | FDA Device (26) |
| By classification | Class II (25), Class III (1) |
| By status | terminated (23), ongoing (3) |
| Distribution named in notices | AL, AZ, CA, CO, DE, FL, GA, HI, IA, IN, KY, LA, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, SC, TN, TX, US, VA |
Recalls
- Orthex Large Bone Shoulder Bolt, model no
FDA Device · Class II · 2023-02-22 · Orthopediatrics
Reason: 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. - Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
FDA Device · Class II · 2022-09-14 · Orthopediatrics
Reason: 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 sur… - Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization o…
FDA Device · Class II · 2020-08-05 · Orthopediatrics
Reason: Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device - OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixati…
FDA Device · Class II · 2020-07-15 · Orthopediatrics
Reason: 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-… - OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixati…
FDA Device · Class II · 2020-07-15 · Orthopediatrics
Reason: 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-… - Model No. 01-1501-0032 (Child Nail Attachment Bolt)
FDA Device · Class II · 2019-11-06 · Orthopediatrics
Reason: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. - Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt)
FDA Device · Class II · 2019-11-06 · Orthopediatrics
Reason: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. - OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant…
FDA Device · Class II · 2019-10-23 · Orthopediatrics
Reason: Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures - Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
FDA Device · Class II · 2018-02-21 · Orthopediatrics
Reason: The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. - Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommend…
FDA Device · Class II · 2017-06-14 · Orthopediatrics
Reason: Over-tensioning of the band resulting in damage to the band causing it to rupture - OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
FDA Device · Class III · 2016-12-28 · Orthopediatrics
Reason: Labeled as a 48mm Cortical Screw but measuring at 50mm - 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage o…
FDA Device · Class II · 2016-09-28 · Orthopediatrics
Reason: 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. - 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage o…
FDA Device · Class II · 2016-09-28 · Orthopediatrics
Reason: 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. - UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilizatio…
FDA Device · Class II · 2016-01-20 · Orthopediatrics
Reason: 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. - 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
FDA Device · Class II · 2015-09-30 · Orthopediatrics
Reason: 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. - 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 Reconstruc…
FDA Device · Class II · 2014-09-10 · Orthopediatrics
Reason: Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. - 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicat…
FDA Device · Class II · 2014-02-12 · Orthopediatrics
Reason: 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 L… - OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation T…
FDA Device · Class II · 2014-01-01 · Orthopediatrics
Reason: Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size. - 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments i…
FDA Device · Class II · 2013-11-20 · Orthopediatrics
Reason: 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, i… - 3.2mm Drill Bit
FDA Device · Class II · 2013-08-21 · Orthopediatrics
Reason: 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 dri… - 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is int…
FDA Device · Class II · 2013-06-19 · Orthopediatrics
Reason: 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. - 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is int…
FDA Device · Class II · 2013-06-19 · Orthopediatrics
Reason: 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. - 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is int…
FDA Device · Class II · 2013-06-19 · Orthopediatrics
Reason: 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. - 4.5mm PLEO Osteotomy Guide
FDA Device · Class II · 2012-11-28 · Orthopediatrics
Reason: 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 specificat… - Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes…
FDA Device · Class II · 2012-11-14 · Orthopediatrics
Reason: 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 functio… - OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right
FDA Device · Class II · 2012-08-01 · Orthopediatrics
Reason: The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.