Home / Recalls / DePuy Orthopaedics, Inc. / Z-0415-2014

Z-0415-2014 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

FDA device recall Z-0415-2014 was initiated by DePuy Orthopaedics, Inc. on Nov 18, 2013 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Feb 24, 2015). Affected quantity: 29,235 units in total / 2008 through November 2013.

Recall Details

Product Type: Devices
Report Date: Dec 4, 2013
Initiation Date: Nov 18, 2013
Termination Date: Feb 24, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 29,235 units in total / 2008 through November 2013

Product Description

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.

Reason for Recall

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.

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

Code Information

Item #950502013

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0415-2014
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by DePuy Orthopaedics, Inc.

Z-1456-2024 Class II — ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6… (Mar 12, 2024)
Z-1265-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part… (Feb 15, 2023)
Z-1263-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part… (Feb 15, 2023)
Z-1264-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part… (Feb 15, 2023)
Z-1267-2023 Class II — Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number… (Feb 15, 2023)
Z-1266-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part… (Feb 15, 2023)
Z-1419-2022 Class II — ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation… (Jun 29, 2022)
Z-1375-2022 Class II — MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic… (May 18, 2022)
Z-1029-2022 Class II — VELYS Robotic-Assisted Solution Base Product No.: 451570100 (Mar 11, 2022)
Z-0632-2022 Class II — ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in… (Jan 5, 2022)