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U.S. Department of Health and Human Services

Class 2 Device Recall SIGMA LCS HIGH PERFORMANCE"

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 Class 2 Device Recall SIGMA LCS HIGH PERFORMANCE"see related information
Date Initiated by FirmNovember 18, 2013
Date PostedNovember 27, 2013
Recall Status1 Terminated 3 on February 24, 2015
Recall NumberZ-0413-2014
Recall Event ID 66864
510(K)NumberK032151 K033272 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductSIGMA 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
Code Information Item #950502011
Recalling Firm/
Manufacturer
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
574-267-8143
Manufacturer 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.
FDA Determined
Cause 2
Device Design
ActionDePuy 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 Commerce29,235 units in total / 2008 through November 2013
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
510(K)s with Product Code = JWH
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