Events

Recall of Device Recall SRom Total Hip System Poly Liner

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
    62765
  • Event Risk Class
    Class 2
  • Event Number
    Z-2414-2012
  • Event Initiated Date
    2012-08-22
  • Event Date Posted
    2012-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111673
  • 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, constrained, cemented or uncemented, metal/polymer - Product Code KWZ
  • Reason
    Orthopaedics, inc. (depuy) is issuing a voluntary recall of four lots of the s-rom" liner because the carton label has an incorrect color code series designation. we have received one complaint regarding this issue.
  • Action
    DePuy sent an "URGENT INFORMATION-MEDICAL DEVICE RECALL NOTICE" dated August 22, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Reconciliation Form was included in the letter for customers to complete and return via fax to 574-371-4939. Contact your local Depuy Orthopaedics sales representative for questions related to this recall.

Device

Device Recall SRom Total Hip System Poly Liner
  • Model / Serial
    Catalogue Lot Number 87-5987 3189424  3312166  3340992  3402685
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of MA, TX, OH, CA, and NC.
  • Product Description
    S-Rom¿ Total Hip System Poly Liner || Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. || Description: Total Hip System Poly Dial¿ Liner is part of the S-ROM¿ Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM¿ stem. The S-ROM liner is used 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. Intended Use: Total Hip System Poly Dial Liner is part of the S-Rom Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-Rom¿ stem. The S Rom liner is used 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