International Medical Devices Database

Manufacturer Address
Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
Manufacturer Parent Company (2017)
Orthofix International Nv
Source
USFDA
30 Events

30 devices in the database

Device Recall Manual General Surgery Drill Guide

Model / Serial
All lot codes
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.
Product Description
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.

Device Recall Rod and screw spinal instrumentation

Model / Serial
Lot Number S29
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.
Product Description
ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse

Device Recall Firebird Spinal Fixation System

Model / Serial
BS535418105, BS535419118, BS535420030, BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039, BS535418127, BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and BS562325023.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- US, Spain, Italy, and Australia.
Product Description
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) || Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).

Device Recall ORTHOFIX, Connector System, SMALL SET SCREW

Model / Serial
UDI 18257200125371, Lot Numbers: O02, O03 and O04
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
US
Product Description
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003

Device Recall ORTHOFIX, Connector System, LARGE SET SCREW

Model / Serial
UDI 18257200125364, Lot Numbers: O01 and O02
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
US
Product Description
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002

25 more

5 manufacturers with a similar name

Learn more about the data here

Orthofix, Inc

Manufacturer Address
Orthofix, Inc, 1720 Bray Central Dr, Mckinney TX 75069-8207
Manufacturer Parent Company (2017)
Orthofix International Nv
Source
USFDA

Orthofix, Inc.

Manufacturer Address
Orthofix, Inc., 3451 Plano Pkwy, Lewisville TX 75056-9453
Manufacturer Parent Company (2017)
Orthofix International Nv
Source
USFDA

Orthofix, Inc.

Manufacturer Parent Company (2017)
Orthofix International Nv
Source
VNSAWH

Orthofix, Inc.

Manufacturer Parent Company (2017)
Orthofix International Nv
Source
SATP

Orthofix, Inc

Manufacturer Address
Orthofix, Inc, 1720 Bray Central Dr, McKinney TX 75069-8207
Manufacturer Parent Company (2017)
Orthofix International Nv
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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