Events

Recall of Device Recall SIGMA LCS HIGH PERFORMANCE"

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Orthopaedics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66864
  • Event Risk Class
    Class 2
  • Event Number
    Z-0418-2014
  • Event Initiated Date
    2013-11-18
  • Event Date Posted
    2013-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123815
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    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.
  • 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

Device

Device Recall SIGMA LCS HIGH PERFORMANCE"
  • Model / Serial
    Item #950502016
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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 Description
    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.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA