Events

Recall of Device Recall Altrx" Altralinked" Polyethylene liners

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
    62649
  • Event Risk Class
    Class 2
  • Event Number
    Z-2220-2012
  • Event Initiated Date
    2012-07-24
  • Event Date Posted
    2012-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111266
  • 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, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Reason
    In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. this resulted in a size 52 liner being etched and labeled as a size 54 liner.
  • Action
    Depuy sent an URGENT MEDICAL DEVICE RECALL notification dated July 24, 2012, to all affected consignees. The recall is extended to the Depuy Distributor level and hospital level. All DePuy Distributors were notified via email. The sales representatives notify the hospital either by mail or in person with a written communication. Distributors and customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN. The sales representatives are expected to aid customer in returning of recalled products. Distributors and sales representatives are to return the recalled products through the normal DePuy Returns process, to attention of Returns and marking H12-16 on the outside of the box. Reconciliation forms should be returned to the DePuy Sales Representative or faxed to 574-372-7567. For clinical questions from Surgeons contact DePuy's Scientific Information Office at 1-888-554-2482. For questions regarding recall information call 574-372-7333.

Device

Device Recall Altrx" Altralinked" Polyethylene liners
  • Model / Serial
    Catalog number: 1221-36-054 and Lot Number: 231859
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including PA and the country of Canada
  • Product Description
    Altrx" Altralinked" Polyethylene liners || Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
  • 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