Events

Recall of Device Recall PFC Sigma Round Dome Patella

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
    59238
  • Event Risk Class
    Class 2
  • Event Number
    Z-3099-2011
  • Event Initiated Date
    2011-06-28
  • Event Date Posted
    2011-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101933
  • 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 initiated a voluntary recall effective immediately, for one lot of p.F.C. sigma rd dome patella 3 peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patellar component. in the recalled lot, the packaging is labeled for a p.F.C. sigma 38mm 3 peg round dome patella, but the product enclosed in the package is a p.F.C. sigma 35mm 3 peg oval dome patella.
  • Action
    The firm, Depuy , sent an email that included a letter entitled "URGENT INFORMATION - RECALL NOTICE" dated June 28, 2011 to DePuy Area customers ( Directors, Distributors, Office Managers, Hospital Representatives, and Doctors). The letter described the product, problem and actions to be taken. The letter also included implications of implanting the recalled device and patient communication information. The customers were instructed to immediately cease further implantation/use or distribution of the product, immediately return any recalled devices in their inventory, notify their customer of the recall and complete, sign and return the Reconciliation Form(s) via fax to DePuy at 574-372-7567 within seven business days. The letter also states that DePuy is not recommending prophylactic revision or additional follow up in the absence of symptoms. Additionally, DePuy recommends that surgeons continue to follow patients as per their standard care. Questions regarding the recall may be directed to the following DePuy representatives--questions about recall information call the Manager of Customer Quality at 574-372-7333; Salesforce questions, call the Group Product Director, 574-372-5046 or Associate Product Director at 574-372-7154 and for Clinical/Surgeon questions, contact DePuy's Scientific Information Office at 1-888-554-2482.

Device

Device Recall PFC Sigma Round Dome Patella
  • Model / Serial
    Product code 960112, Lot number 3292209
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: CA, MI, NJ and WI.
  • Product Description
    PFC Sigma Round Dome Patella 38 MM 3 Peg || Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cement.
  • 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