Events

Recall of Device Recall Reflection, Microstable 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
    50543
  • Event Risk Class
    Class 2
  • Event Number
    Z-1004-2009
  • Event Initiated Date
    2008-11-21
  • Event Date Posted
    2009-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75728
  • 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
    Liners measuring 28 mm id and were mismarked as 32 mm.
  • Action
    All affected Smith & Nephew International Distributors were notified via e-mail dated November 24, 2008. In a letter titled "Urgent: Product Recall Notice - Immediate Action Required", distributors were instructed to immediately notify their accounts concerning the recall. All affected product is to be located and returned to the firm immediately. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-5441.

Device

Device Recall Reflection, Microstable Acetabular Liner
  • Model / Serial
    Part Number: 71740250, Lot Numbers: 08FM05400 and 08FM05400B.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    International Distribution to Canada, France, Germany and Switzerland.
  • Product Description
    Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

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