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Orthofix, Inc.

Last updated May 24, 2026

What Orthofix, Inc. makes

Orthofix, Inc. manufactures orthopaedic fixation devices, including non-bioabsorbable bone screws (both sterile and non-sterile), external fixation systems (single-use and reusable), and intramedullary nails for long bones and the femur. Their portfolio also includes plating systems for fracture fixation, such as proximal humeral and supracondylar plates, as well as specialized reconstruction systems for limb stabilization.

The company’s devices are regulated under FDA’s Class I and Class II classifications and are listed in the FDA’s Unique Device Identification (UDI) database. Orthofix, Inc. is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
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Catalogue (7521)

Page 1 of 151

Device	Model / Reference	Registries	Class	Status
Fitbone Taa System	1	FDA UDI	Class II	Active
Contours Proximal Humeral Plate (PHP)	1	FDA UDI	Class II	Active
Juniortho Plating System	1	FDA UDI	Class II	Active
Oscar 3	1	FDA UDI	Class II	Active
View Plating System - Reduce Fracture Plating System	1	FDA UDI	Class II	Active
View Plating System - Reduce Fracture Plating System	1	FDA UDI	Class II	Active
Centronail Titanium Supracondylar Nailing System	1	FDA UDI	Class II	Active
HA Bone Screws	1	FDA UDI	Class II	Active
Stainless Steel Femoral Nailing System	1	FDA UDI	Class II	Active
Agile Nail	1	FDA UDI	Class II	Active
Adult Limb Reconstruction System	1	FDA UDI	Class II	Active
Stainless Steel Tibial Nailing System	1	FDA UDI	Class II	Active
Juniortho Plating System	1	FDA UDI	Class II	Active
Stainless Steel Tibial Nailing System	1	FDA UDI	Class II	Active
View Plating System - Reduce Fracture Plating System	1	FDA UDI	Class II	Active
Centronail Titanium Humeral Nailing System	1	FDA UDI	Class II	Active
View Plating System, Reduce Fracture Plating System	1	FDA UDI	Class II	Active
Stainless Steel Femoral Nailing System	1	FDA UDI	Class II	Active
Bite Compression Screws	1	FDA UDI	Class II	Active
Stainless Steel Femoral Nailing System	1	FDA UDI	Class II	Active
Orthofix	1	FDA UDI	Class II	Active
Orthofix	1	FDA UDI	Class I	Active
Procallus Fixator	1	FDA UDI	Class II	Active
Centronail Titanium Humeral Nailing System	1	FDA UDI	Class II	Active
View Plating System, Reduce Fracture Plating System	1	FDA UDI	Class II	Unknown
Centronail Titanium Tibial Nailing System	1	FDA UDI	Class II	Active
View Plating System - Reduce Fracture Plating System	1	FDA UDI	Class II	Active
Orthofix	1	FDA UDI	Class II	Active
Juniortho Plating System	1	FDA UDI	Class II	Active
Orthofix	1	FDA UDI	Class II	Active
Juniortho Plating System	1	FDA UDI	Class II	Active
View Plating System, Reduce Fracture Plating System	1	FDA UDI	Class II	Active
Juniortho Plating System	1	FDA UDI	Class II	Active
Orthofix	1	FDA UDI	Class II	Active
Hybrid Fixator System	1	FDA UDI	Class II	Active
CHIMAERA Hip Fracture System	1	FDA UDI	Class II	Active
View Plating System, Reduce Fracture Plating System	1	FDA UDI	Class II	Active
View Plating System, Reduce Fracture Plating System	1	FDA UDI	Class II	Active
View Plating System - Reduce Fracture Plating System	1	FDA UDI	Class II	Active
Small Blue D.a.f.	1	FDA UDI	Class II	Active
Elbow Fixator	1	FDA UDI	Class II	Active
Centronail Titanium Humeral Nailing System	1	FDA UDI	Class II	Active
Xcaliber Bone Screws	1	FDA UDI	Class II	Active
Bite Compression Screws	1	FDA UDI	Class II	Active
Orthofix	1	FDA UDI	Class II	Active
Stainless Steel Tibial Nailing System	1	FDA UDI	Class II	Active
Bite Compression Screws	1	FDA UDI	Class II	Active
Orthofix	1	FDA UDI	Class II	Active
Juniortho Plating System	1	FDA UDI	Class II	Active
Sole Medial Column Fusion Plate	1	FDA UDI	Class II	Active

Related Companies

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FDA Recalls (39)

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

Orthofix, Inc. has 39 FDA recall records initiated between September 28, 2007, and April 6, 2018, all marked as terminated. The recalls involve various orthopedic devices, including limb lengtheners, spinal fixation systems, screws, plates, cutters, and surgical tools, with reasons citing potential device malfunctions such as incorrect markings, size discrepancies, locking mechanism failures, and manufacturing defects. Some recalls were voluntary and tied to specific lot numbers, while others addressed broader design or performance concerns based on customer complaints or internal investigations.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 6, 2018	Z-2118-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2131-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2130-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2132-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2128-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2120-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2126-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2117-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2135-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2119-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2122-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2116-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2124-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2123-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2125-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2133-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2129-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2134-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2127-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Apr 6, 2018	Z-2121-2018	—	terminated	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Feb 23, 2018	Z-1364-2018	—	terminated	Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
Feb 23, 2018	Z-1363-2018	—	terminated	Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
Aug 2, 2017	Z-3127-2017	—	terminated	The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.
Apr 27, 2016	Z-1881-2016	—	terminated	There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.
Jan 8, 2016	Z-0797-2016	—	terminated	There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
May 18, 2015	Z-1749-2015	—	terminated	The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.
May 11, 2015	Z-1819-2015	—	terminated	There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.
Nov 26, 2013	Z-0855-2014	—	terminated	Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery.
Oct 29, 2013	Z-1089-2014	—	terminated	There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Feb 1, 2013	Z-0896-2013	—	terminated	There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.
Aug 6, 2012	Z-0895-2013	—	terminated	There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.
Feb 6, 2012	Z-1037-2012	—	terminated	The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.
Apr 1, 2011	Z-3162-2011	—	terminated	Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse.
Oct 22, 2010	Z-1674-2011	—	terminated	There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.
Oct 22, 2010	Z-1608-2011	—	terminated	There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.
Oct 18, 2010	Z-0590-2011	—	terminated	Outer cartons for the product may be labeled with incorrect needle gauge.
Nov 19, 2009	Z-0641-2010	—	terminated	The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning.
Oct 9, 2009	Z-0262-2010	—	terminated	ISKD lengthening device has the potential for not pre-distracting. This may cause or contribute to device malfunction, and if not discovered prior to use, may require surgical re-intervention or removal.
Sep 28, 2007	Z-0674-2008	—	terminated	Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.