Events

Recall of Device Recall REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER

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
    67042
  • Event Risk Class
    Class 2
  • Event Number
    Z-0581-2014
  • Event Initiated Date
    2013-11-25
  • Event Date Posted
    2013-12-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124594
  • 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
    One batch of the reflection(tm) polyethylene acetabular liners may be out of tolerance causing the liner not to fully seat into the shell.
  • Action
    All affected sales staff was notified of problem and the recall via email on 11/25/2013. There were no US hospitals affected by this recall.

Device

Device Recall REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER
  • Model / Serial
    Batch No. 12BM04836
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in China and Spain.
  • Product Description
    REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. || 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