Orthofix, Inc. devices, product family

Manufacturer

Orthofix, Inc.(190)·ORTHOFIX SRL(10)

Several manufacturer records share this Basic UDI-DI.

Basic UDI-DI

805050436EXFIX1NACDB

Risk class

Class II·Class I (varies)

Legislation

MDR

EMDN category

AXIAL BONE FIXATION SYSTEMS

Market status

200 on the market

Official record

EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 805050436EXFIX1NACDB.

• Z-2730-2026 ·Class II · ongoing · 10 Jun 2026
  Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
• Z-2732-2026 ·Class II · ongoing · 10 Jun 2026
  Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
• Z-2729-2026 ·Class II · ongoing · 10 Jun 2026
  Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
• Z-2731-2026 ·Class II · ongoing · 10 Jun 2026
  Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
• Z-0383-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0374-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0400-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0401-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0373-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0399-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0393-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0379-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0391-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0398-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0384-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0381-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0390-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0375-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0382-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
• Z-0380-2020 ·Class II · terminated · 27 Sep 2018
  As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

Recalls matched to the 50 devices listed on this page; other pages of the family can carry others.