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ORTHOPEDIATRICS CORP.

United States·US-MF-000001776

Last updated May 24, 2026

Information

Country: United States
Address: 2850, Frontier Dr, Warsaw, United States
Website: www.orthopediatrics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(574) 268-6379
PRRC Contact: Yan Li
EUDAMED SRN: US-MF-000001776
FDA FEI Number: —
DUNS Number: 796416191

Catalogue (12790)

Page 1 of 256

Device	Model / Reference	Registries	Class	Status
Orthex External Fixation System	Z402-285-48	FDA UDI	Class I	Active
SCFE Screw	00-1071-4030	FDA UDI	Class II	Active
PediLoc Locking Plate System	00-1050-4630	FDA UDI	Class II	Active
PediLoc Fragment System	00-1005-3806	FDA UDI	Class II	Active
PediNail Intramedullary Platform	00-1506-3090	FDA UDI	Class II	Active
Response Spine System	00-1300-4765	FDA UDI	Class II	Active
Pediatric Nailing Platform Femur	00-1504-0944	FDA UDI	Class II	Active
Locking Cannulated Blade Plate (LCB)	01-1200-0051	FDA UDI	Class I	Active
3P Hip System	00-3066-3310L	FDA UDI	Class II	Active
3P Hip System	01-3006-3002	FDA UDI	Class I	Active
OrthoPediatrics Cannulated Screw System	01-1400-1015	FDA UDI	Class II	Active
OrthoPediatrics PediFoot Deformity Correction System	01-1007-1844	FDA UDI	Class II	Active
PediNail Intramedullary Platform	01-1501-0037	FDA UDI	Class I	Active
Response 5.5/6.0 Spine System	01-1300-6035	FDA UDI	Class II	Active
Response Spine 5.5/6.0 System	00-1300-2765	FDA UDI	Class II	Active
Response Spine System	00-1300-4645	FDA UDI	Class II	Active
Locking Cannulated Blade Plate	01-1200-4200	FDA UDI	Class I	Active
General Instrument	01-1300-0030	FDA UDI	Class I	Active
Orthopediatrics Cannulated Screw System	00-1402-6045	FDA UDI	Class II	Active
Response 4.5/5.0 Spine System	00-1600-3525	FDA UDI	Class II	Active
Response 4.5/5.0 Spine System	00-1600-2750	FDA UDI	Class II	Active
Orthex	C350-M4-02	FDA UDI	Class II	Active
General Instruments	01-1008-0070	FDA UDI	Class I	Active
eZ-Fix	300-025S	FDA UDI	Class II	Active
Locking Proximal Femur Plate System	00-0907-1404	FDA UDI	Class II	Active
Response Spine System	00-1300-3980	FDA UDI	Class II	Active
Pediatric Nailing Platform Femur	00-1503-1044	FDA UDI	Class II	Active
Pediatric Nailing Platform \| Tibia	00-1510-9200	FDA UDI	Class II	Active
Orthex External Fixation System	R320-180-GOLD	FDA UDI	Class II	Active
Orthex/ Instrument Case	01-2200-0104	FDA UDI	Class I	Active
Orthex	C-Ball	FDA UDI	Class II	Active
OrthoPediatrics Cannulated Screw System	01-1400-0048	FDA UDI	Class II	Active
PNP Femur	00-1506-4063-S	FDA UDI	Class II	Active
Orthopediatrics Cannulated Screw System	00-1402-1058	FDA UDI	Class II	Active
PNP Femur	00-1504-1032-S	FDA UDI	Class II	Active
OrthoPediatrics Cannulated Screw System	00-1400-6916	FDA UDI	Class II	Active
Response Spine 5.5/6.0 System	00-1300-2865	FDA UDI	Class II	Active
Response Spine 5.5/6.0 System	00-1300-0440	FDA UDI	Class II	Active
3P Hip System	00-3063-2123	FDA UDI	Class II	Active
3P Hip System	00-3066-3306L	FDA UDI	Class II	Active
Response Spine 5.5/6.0 System	00-1300-0665	FDA UDI	Class II	Active
Response Spine 5.5/6.0 System	00-1300-2570	FDA UDI	Class II	Active
PNP Femur	00-1506-5044-S	FDA UDI	Class II	Active
PediNail Intramedullary Platform	00-1506-2076	FDA UDI	Class II	Active
OrthoPediatrics Cannulated Screw System	00-1400-6682	FDA UDI	Class II	Active
Orthex	K250-12BN	FDA UDI	Class II	Active
Orthopediatrics Instrumentation	01-1402-1010	FDA UDI	Class I	Active
OrthoPediatrics Cannulated Screw System	01-1400-0098	FDA UDI	Class II	Active
Orthex Half Pin	HP60-150-55B	FDA UDI	Class II	Active
Response 5.5/6.0 Spine System	00-1350-7525	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (52)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 12, 2022	Z-0277-2023	—	open, classified	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.
Jun 29, 2022	Z-1678-2022	—	open, classified	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
Jul 6, 2020	Z-2742-2020	—	open, classified	Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
Jun 5, 2020	Z-2538-2020	—	terminated	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.
Jun 5, 2020	Z-2539-2020	—	terminated	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.
Aug 19, 2019	Z-0125-2020	—	terminated	Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Aug 19, 2019	Z-0218-2020	—	terminated	Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Aug 19, 2019	Z-0219-2020	—	terminated	Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Aug 3, 2017	Z-0597-2018	—	terminated	The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Apr 24, 2017	Z-2321-2017	—	terminated	Over-tensioning of the band resulting in damage to the band causing it to rupture
Nov 18, 2016	Z-0879-2017	—	terminated	Labeled as a 48mm Cortical Screw but measuring at 50mm
Jul 27, 2016	Z-2844-2016	—	terminated	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.
Jul 27, 2016	Z-2843-2016	—	terminated	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.
Nov 10, 2015	Z-0622-2016	—	terminated	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.
Jul 28, 2015	Z-2796-2015	—	terminated	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.
Jul 25, 2014	Z-2560-2014	—	terminated	Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Jan 8, 2014	Z-0934-2014	—	terminated	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.
Nov 7, 2013	Z-0579-2014	—	terminated	Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
Sep 26, 2013	Z-0276-2014	—	terminated	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.
Jul 24, 2013	Z-1941-2013	—	terminated	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
Apr 19, 2013	Z-1535-2013	—	terminated	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.
Apr 19, 2013	Z-1536-2013	—	terminated	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.
Apr 19, 2013	Z-1534-2013	—	terminated	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.
Oct 18, 2012	Z-0432-2013	—	terminated	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.
Sep 13, 2012	Z-0207-2013	—	terminated	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.
Jun 14, 2012	Z-2057-2012	—	terminated	The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Jul 21, 2009	Z-0356-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0344-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0358-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0362-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0349-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0354-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0348-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-034-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0351-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0359-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0363-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0342-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0350-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0339-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0364-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0347-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0345-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0361-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0341-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0346-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0352-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0343-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0360-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0355-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0357-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0353-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.