Events

Recall of Device Recall R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew 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
    65370
  • Event Risk Class
    Class 2
  • Event Number
    Z-1928-2013
  • Event Initiated Date
    2013-05-29
  • Event Date Posted
    2013-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118701
  • 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, uncemented, metal/polymer, porous - Product Code MBL
  • Reason
    One batch of 60 mm 20o r3 xlpe liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o r3 xlpe liner may be laser etched and packaged as a 60 mm 20o liner.
  • Action
    All affected Smith & Nephew Sales Representatives were notified of problem and the recall via email on 5/29. They were instructed to cease use and distribution of the product and quarantine for return. Surgeons were notified by letter beginning on 6/12. International consignees were notified on 05/29 via email.

Device

Device Recall R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD
  • Model / Serial
    Batch No. 12FM00603
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom.
  • Product Description
    R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. || Orthopaedic.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Manufacturer Address
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA