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.
June 25, 2025Medical DevicesFDA
Orthofix Srl recalls REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Hazard: Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
November 20, 2019Medical DevicesFDA
Orthofix Srl recalls ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
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: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
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: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
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:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
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: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
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: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)1805424
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: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
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: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
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: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
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: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
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: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
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: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 1
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: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 1803
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: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 180
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: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
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: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
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: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
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: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18
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 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, U
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 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UD
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 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, U
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 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Ste
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 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non St
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 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Steril
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 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)180325680
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 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)180325680
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 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568
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 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568
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 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568
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.