thejoe Orthofix Srl

Orthofix Srl: 34 FDA recall reports

Every medical device recall the FDA has published for Orthofix Srl. The fault, and how the agency graded it.

34Reports

0Class I

1Ongoing

2025-06-25Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	34

By year reported

Year	Reports
2018	2
2019	31
2025	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile

Z-1977-2025 · Class II · reported 2025-06-25 · Ongoing

Why it was recalled: Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
Product: REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Where it went: US: Unknown, OUS: Unknown
How much: 2 units

ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01

Z-0378-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non

Z-0383-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI

Z-0390-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)180329

Z-0387-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01

Z-0379-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (0

Z-0375-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656

Z-0403-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non

Z-0385-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)

Z-0374-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI:

Z-0391-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (

Z-0398-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922

Z-0400-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908

Z-0394-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non S

Z-0384-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (0

Z-0377-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)180542425108

Z-0395-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (0

Z-0376-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY,

Z-0380-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304

Z-0401-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ON

Z-0381-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719

Z-0389-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298

Z-0399-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)1803350985991

Z-0397-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855

Z-0393-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)

Z-0373-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, U

Z-0386-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533

Z-0402-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI

Z-0392-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281

Z-0396-2020 · Class II · reported 2019-11-20 · Terminated

Why it was recalled: 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.
Product: ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
Where it went: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
How much: N/A

Showing the 30 most recent of 34. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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