Z-0419-2014Class II

SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to...

Name: Z-0419-2014 SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to...
Creator: DePuy Orthopaedics, Inc.
Published: 2013-11-18
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2013-11-18 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of 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... on 2013-11-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0419-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-18
Posted: 2013-11-27
Terminated: 2015-02-24
Recalling firm: Depuy Orthopaedics Inc.
Product: 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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: design
FDA root cause: Device Design
Action: DePuy Orthopaedics sent an Urgent Information - Medical Device Correction letter to all affected customers on November 18, 2013. Immediately after initiation on November 18, the company halted initiation with our US distributors and international affiliates because the surgical technique referenced and images from the surgical technique were not correct. No surgeons received the November 18 surgeon letter. The recall was re-initiated on November 20, 2013. The communication to the surgeons who used the affected devices will be delivered by Distributors either by mail or in person and includes the surgeon letter. The device correction includes awareness, reiteration of surgical techniques and instrument care, and visual check of the device as outlined in the Field Notice and Surgeon letter. The devices are not being removed from the market, but the company is investigating potential design changes to the HP M.B.T. Keel Punch Knee Instrument to reduce the potential for the tabs to fracture. All DePuy United States Distributors and DePuy affiliate contacts for Canada, Latin America and International will be notified via email. The US Distributors will identify surgeons who use the affected instruments on Distributor Response Card #1. The US Distributor will notify surgeons either by mail or in person with the written communication. Once all device correction activities are complete, the US Distributor will complete and return Distributor Card #2 to DePuy Orthopaedics, Inc. The US distributors are the US consignees and are responsible for notifying all new HP M.B.T. Keel Punch Knee Instrument surgeon users of this device correction. All territories are required to ensure the HP M.B.T. Keel Punch Knee Instrument Device Correction is promptly initiated. Customers were asked to review the instructions included, along with the attached documents, which contain important information regarding notification of surgeons affected by this Device Correction. Customers
Quantity in commerce: 29,235 units in total / 2008 through November 2013
Distribution: 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
Product codes and lots: Item #950502017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0419-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0412-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0413-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0414-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0415-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0416-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0417-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0418-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0419-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0420-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0421-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0422-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27
Z-0423-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-27

Product code JWH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)