Orthofix Srl Recalls
34 recalls on record · January 3, 2018 to June 25, 2025 · Medical Devices
Recalls by year
18
19
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 20, 2019Medical DevicesFDA
Orthofix Srl recalls ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)1803256803
Hazard: 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.
November 20, 2019Medical DevicesFDA
Orthofix Srl recalls ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)1803256803
Hazard: 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.
June 13, 2018Medical DevicesFDA
Orthofix Srl recalls TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM.
Hazard: The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after September 2016. The firm determined that certain batches of the double row footplates are not compatible with the current version of the TL-HEX struts.
January 3, 2018Medical DevicesFDA
Orthofix Srl recalls Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal
Hazard: The power drill torque limiter may break during use in surgery application.