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.
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 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502010
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 2 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502011
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 3 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502012
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 4 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502013
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 5 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502014
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 6 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502015
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 7 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502016
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 8 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502017
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 9 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502018
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 10 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502019
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 11 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502020
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
device · product 12 of 12
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
29,235 units in total / 2008 through November 2013
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
These labels are deterministic app interpretations, not FDA categories.
DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Code information
Item #950502021
Distribution pattern
Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK
