Orthopediatrics Corp.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000001776
- Devices
- 17,001
- Registrations
- EUDAMED
- FDA recalls
- 522 ongoing since 2021 (3 open in total)
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA recalls
- Authorised rep.
- Emergo Europe B.V.NL
What Orthopediatrics Corp. makes
Orthopaediatrics Corp. manufactures orthopaedic hardware for bone fixation, including non-sliding and non-bioabsorbable bone screws, intramedullary nails for the femur and tibia, and orthopaedic plates. Their portfolio also includes reusable surgical procedure kits, external fixation systems, and pediatric-specific devices like locking plates, screws, and intramedullary nailing platforms. Examples include the PediNail Intramedullary Platform for pediatric femur nailing, the SCFE screw for slipped capital femoral epiphysis, and the Response Spine System for spinal fixation.
The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIb, with corresponding entries in the FDA’s Unique Device Identifier (UDI) database and the EU’s eudamed registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 17,001 devicesShowing 1-50 of 17,001
Company details
- EUDAMED SRN
- US-MF-000001776
- DUNS number
- 796416191
- EUDAMED status
- Active
- EUDAMED registered name
- OrthoPediatrics Corp.
- EUDAMED abbreviated name
- OrthoPediatrics Corp.
- Registered address
- 2850, Frontier Dr, 46582, Warsaw, United States
- Website
- www.orthopediatrics.com
- [email protected]
- Phone
- +1(574) 268-6379
- PRRC contact
- Yan Li
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 7 Dec 2030
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 780188 Active
Quality management system EU MDR
- Issued
- 26 Aug 2026
- Expires
- 7 Dec 2030
- Reason
- Other
FDA recalls
FDA recall records list 52 recalls initiated by ORTHOPEDIATRICS CORP., the earliest on 2009-07-21 and the most recent on 2022-09-12. By recorded status: 3 ongoing and 49 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 3
- 2020 3
- 2021 0
- 2022 2
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 12 Sep 2022 Z-0277-2023 Class II Ongoing 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.
- 29 Jun 2022 Z-1678-2022 Class II Ongoing 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
2020
- 6 Jul 2020 Z-2742-2020 Class II Open since 2020 Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
- 5 Jun 2020 Z-2538-2020 Class II 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.
- 5 Jun 2020 Z-2539-2020 Class II 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.
2019
- 19 Aug 2019 Z-0125-2020 Class II Terminated Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
- 19 Aug 2019 Z-0218-2020 Class II Terminated Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Full distribution text
- 19 Aug 2019 Z-0219-2020 Class II Terminated Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Full distribution text
2017
- 3 Aug 2017 Z-0597-2018 Class II Terminated The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
- 24 Apr 2017 Z-2321-2017 Class II Terminated Over-tensioning of the band resulting in damage to the band causing it to rupture
Show the 25 most recent of 52 recalls
2016
- 18 Nov 2016 Z-0879-2017 Class III Terminated Labeled as a 48mm Cortical Screw but measuring at 50mm
Full distribution text
- 27 Jul 2016 Z-2843-2016 Class II 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.
Full distribution text
- 27 Jul 2016 Z-2844-2016 Class II 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.
Full distribution text
- 18 Nov 2016 Z-0879-2017 Class III Terminated Labeled as a 48mm Cortical Screw but measuring at 50mm
2015
- 10 Nov 2015 Z-0622-2016 Class II 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.
- 28 Jul 2015 Z-2796-2015 Class II 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.
2014
- 25 Jul 2014 Z-2560-2014 Class II Terminated Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
- 8 Jan 2014 Z-0934-2014 Class II 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.
Full distribution text
2013
- 7 Nov 2013 Z-0579-2014 Class II 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.
- 26 Sep 2013 Z-0276-2014 Class II 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.
- 24 Jul 2013 Z-1941-2013 Class II 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
- 19 Apr 2013 Z-1534-2013 Class II 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.
- 19 Apr 2013 Z-1535-2013 Class II 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.
- 19 Apr 2013 Z-1536-2013 Class II 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.
2012
- 18 Oct 2012 Z-0432-2013 Class II 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.
- 13 Sep 2012 Z-0207-2013 Class II 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.
Frequently asked questions
How many devices does ORTHOPEDIATRICS CORP. have in the registry?
The registry currently lists 17001 devices for ORTHOPEDIATRICS CORP.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ORTHOPEDIATRICS CORP.'s devices?
Among its 50 most recently registered devices, ORTHOPEDIATRICS CORP. has devices listed in EUDAMED (50 devices).
What risk classes do ORTHOPEDIATRICS CORP.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ORTHOPEDIATRICS CORP.'s devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
Are there FDA recall records for ORTHOPEDIATRICS CORP.?
FDA recall records list 52 recalls initiated by ORTHOPEDIATRICS CORP., the most recent initiated on 12 Sep 2022. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for ORTHOPEDIATRICS CORP.?
EUDAMED lists 1 certificate for ORTHOPEDIATRICS CORP. (quality management system) under MDR. The most recent was issued on 26 Aug 2026.
What are the newest devices from ORTHOPEDIATRICS CORP. in the registry?
The most recently registered devices listed for ORTHOPEDIATRICS CORP. include ORTHOPEDIATRICS® LOCKING PROXIMAL FEMUR PLATE SYSTEM DISTAL FEMORAL OSTEOTOMY SYSTEM, ORTHOPEDIATRICS® INSTRUMENTATION, ORTHOPEDIATRICS® PEDILOC™ FRAGMENT SYSTEM and ORTHOPEDIATRICS® PEDINAIL™ INTRAMEDULLARY NAILING SYSTEM.