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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84004

31 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 27, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Orthofix Srl

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

31 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 31

ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959

Z-0373-2020
Recall number
Z-0373-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1200908

Distribution pattern

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

device · product 2 of 31

ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120

Z-0374-2020
Recall number
Z-0374-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1200674, B1209688

Distribution pattern

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

device · product 3 of 31

ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867

Z-0375-2020
Recall number
Z-0375-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1208414, B1218188, 289817, 273349

Distribution pattern

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

device · product 4 of 31

ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867

Z-0376-2020
Recall number
Z-0376-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1202045, B1206643, B1218524, 289818, 273350

Distribution pattern

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

device · product 5 of 31

ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911

Z-0377-2020
Recall number
Z-0377-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1202045, B1206643, B1218524, 273351

Distribution pattern

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

device · product 6 of 31

ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966

Z-0378-2020
Recall number
Z-0378-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1200720, 289819, 273352

Distribution pattern

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

device · product 7 of 31

ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137

Z-0379-2020
Recall number
Z-0379-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1215075, 303106, 289822, 273357

Distribution pattern

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

device · product 8 of 31

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

Z-0380-2020
Recall number
Z-0380-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1200713, 289813, 289813,300237, 300237, 300238, 289813, 273342

Distribution pattern

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

device · product 9 of 31

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

Z-0381-2020
Recall number
Z-0381-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1205238, B1205760, B1213842, 289814, 300239, 289814, 273343

Distribution pattern

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

device · product 10 of 31

ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075

Z-0382-2020
Recall number
Z-0382-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1203608, B1210965, B1211752, B1214172,B1218793, 300241,300240,273169

Distribution pattern

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

device · product 11 of 31

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

Z-0383-2020
Recall number
Z-0383-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1199835, 289815, 289815, 273344

Distribution pattern

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

device · product 12 of 31

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

Z-0384-2020
Recall number
Z-0384-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1209082 and 273347

Distribution pattern

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

device · product 13 of 31

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

Z-0385-2020
Recall number
Z-0385-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # 300244, 300243, 289816, 273348

Distribution pattern

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

device · product 14 of 31

ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648

Z-0386-2020
Recall number
Z-0386-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1200654, B1205554, B1208340, B1215045, B1215995, B1232424

Distribution pattern

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

device · product 15 of 31

ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696

Z-0387-2020
Recall number
Z-0387-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1207402, B1209817, B1211407, B1212676, B1229618, B1232423, B1233324, B1233663

Distribution pattern

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

device · product 16 of 31

ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791

Z-0388-2020
Recall number
Z-0388-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1201157, B1203789, B1226060

Distribution pattern

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

device · product 17 of 31

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

Z-0389-2020
Recall number
Z-0389-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1206515, B1206561, B1209206, B1211406, B1212677, B1215964, B1233839

Distribution pattern

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

device · product 18 of 31

ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948

Z-0390-2020
Recall number
Z-0390-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1207286, B1207428, B1211384, B1215263 *Not marketed in US

Distribution pattern

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

device · product 19 of 31

ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955

Z-0391-2020
Recall number
Z-0391-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1209789 *Not marketed in US

Distribution pattern

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

device · product 20 of 31

ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962

Z-0392-2020
Recall number
Z-0392-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1207287 *Not marketed in US

Distribution pattern

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

device · product 21 of 31

ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979

Z-0393-2020
Recall number
Z-0393-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1207288, B1215312, B1228971, B1233730 *Not marketed in US

Distribution pattern

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

device · product 22 of 31

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

Z-0394-2020
Recall number
Z-0394-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1200694, B1204116, B1224715, B1232315

Distribution pattern

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

device · product 23 of 31

ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888

Z-0395-2020
Recall number
Z-0395-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1202055, B1225324, B1225854, B1226694, B1228037, B1228211, B1228361, B1228547, B1231459

Distribution pattern

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

device · product 24 of 31

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

Z-0396-2020
Recall number
Z-0396-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1225391

Distribution pattern

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

device · product 25 of 31

ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915

Z-0397-2020
Recall number
Z-0397-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot # B1200709, B1204115, B1206439, B1225414, B1233729

Distribution pattern

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

device · product 26 of 31

ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895

Z-0398-2020
Recall number
Z-0398-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: B1202062, B1224660, B1227924, B1231700

Distribution pattern

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

device · product 27 of 31

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

Z-0399-2020
Recall number
Z-0399-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: B1225603

Distribution pattern

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

device · product 28 of 31

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

Z-0400-2020
Recall number
Z-0400-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: B1200695, B1224714

Distribution pattern

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

device · product 29 of 31

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

Z-0401-2020
Recall number
Z-0401-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: B1200695, B1224714

Distribution pattern

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

device · product 30 of 31

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

Z-0402-2020
Recall number
Z-0402-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: B1203702, B1205553, B1209103, B1212944, B1215607, B1219056, B1212544

Distribution pattern

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

device · product 31 of 31

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

Z-0403-2020
Recall number
Z-0403-2020
Initiated
September 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Orthofix Srl
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
does not correspond to the intended design

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Lot #: 81213075, 81215044, 81216539, 81217847, 81234691

Distribution pattern

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