Events

Recall of Device Recall DePuy Orthopaedics LCS COMPLETE RPS

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
    71085
  • Event Risk Class
    Class 2
  • Event Number
    Z-1673-2015
  • Event Initiated Date
    2015-03-04
  • Event Date Posted
    2015-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136058
  • 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, metal/polymer, mobile bearing - Product Code NJL
  • Reason
    The lcs complete rps knee system has higher rates of revision in australia when the native patella is not resurfaced when compared to other unresurfaced ps implants. if the lcs complete rps knee system is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.
  • Action
    On 3/4/2015, URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System and on 3/19/2015 REVISED URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System (Revised) notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. to 5 p.m. EDT).

Device

Device Recall DePuy Orthopaedics LCS COMPLETE RPS
  • Model / Serial
    All Lots. Catalog numbers: 129416110 129416112 129416115 129416117 129416120 129416122 129416125 129416210 129416212 129416215 129416217 129416220 129416222 129416225 129416310 129416312 129416315 129416317 129416320 129416322 129416325 129416410 129416412 129416415 129416417 129416420 129416422 129416425 129416510 129416512 129416515 129416517 129416520 129416522 129416525 129416610 129416612 129416615 129416617 129416620 129416622 129416625 129416710 129416712 129416715 129416717 129416720 129416722 129416725 129417110 129417112 129417115 129417117 129417120 129417122 129417125 129417210 129417212 129417215 129417217 129417220 129417222 129417225 129417310 129417312 129417315 129417317 129417320 129417322 129417325 129417410 129417412 129417415 129417417 129417420 129417422 129417425 129417510 129417512 129417515 129417517 129417520 129417522 129417525 129417610 129417612 129417615 129417617 129417620 129417622 129417625 129417710 129417712 129417715 129417717 129417720 129417722 129417725 129495410 129495412 129495415 129495417 129495420 129495510 129495512 129495515 129495517 129495520 129495610 129495612 129495615 129495617 129495620
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.
  • Product Description
    LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
  • 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