Orthopediatrics Corp
Warsaw, IN
This page shows every FDA and USDA recall linked to Orthopediatrics Corp. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
52
Total Recalls
2009
First Recall
2022
Most Recent
Orthex Large Bone Shoulder Bolt, model no. AS-17
Nov 22, 2022
· Device
Open, Classified
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm
Model: K400-18BN
Jun 29, 2022
· Device
Open, Classified
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immob...
Jul 6, 2020
· Device
Open, Classified
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product...
Jun 5, 2020
· Device
Terminated
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product...
Jun 5, 2020
· Device
Terminated
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Produc...
Aug 19, 2019
· Device
Terminated
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- inte...
Aug 19, 2019
· Device
Terminated
Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usag...
Aug 19, 2019
· Device
Terminated
Response 5.5/6.0 Spine System 7.0mm x 40mm
Pedicle Screw
Product Usage:
Posterior non-cervical pedicle scre...
Aug 3, 2017
· Device
Terminated
Response BandLoc 5.5/6.0 Tensioner Instrument
The Tensioner Instrument (01-1102-1000) is utilized to allow th...
Apr 24, 2017
· Device
Terminated
OrthoPediatrics PediNail Intramedullary Nailing System
4.5mm X 48mm Cortical Screw
Dec 22, 2016
· Device
Terminated
3.5mm Bowed Locking Compression Femur Plates, 14 hole
Orthopediatrics PediLoc Locking Plate System comes in se...
Sep 19, 2016
· Device
Terminated
3.5mm Bowed Locking Compression Femur Plates, 18 hole
Orthopediatrics PediLoc Locking Plate System comes in se...
Sep 19, 2016
· Device
Terminated
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw
The Response 5.5/6.0 Spine System is intended for i...
Nov 10, 2015
· Device
Terminated
3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System
Part number 00-0903-2510, 3.5mm x 10mm No...
Sep 18, 2015
· Device
Terminated
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm
Product Usage:
The...
Aug 29, 2014
· Device
Terminated
3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm
Part No. 00-0903-2620
OrthoPediatrics Ped...
Feb 6, 2014
· Device
Terminated
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system con...
Dec 26, 2013
· Device
Terminated
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM
The OrthoPediatrics Proximal Femur Plating System combi...
Nov 14, 2013
· Device
Terminated
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in b...
Aug 9, 2013
· Device
Terminated
90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannu...
Jun 12, 2013
· Device
Terminated
90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannu...
Jun 12, 2013
· Device
Terminated
90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannu...
Jun 12, 2013
· Device
Terminated
4.5mm PLEO Osteotomy Guide.
OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system....
Nov 22, 2012
· Device
Terminated
Trochar Scalpel Instrument (Surgical Punch)
OrthoPediatrics intramedullary rods (nails) are generally rod-sha...
Nov 5, 2012
· Device
Terminated
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right.
Use...
Jul 20, 2012
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-03...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-03...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-02...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-02...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-02...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-08...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-08...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-07...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-025....
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-08...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-07...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-07...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-07...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-08...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-08...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-03...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-07...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-03...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-02...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-07...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-02...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-03...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-08...
May 12, 2010
· Device
Terminated
Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-08...
May 12, 2010
· Device
Terminated