Events

Recall of Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD

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
    72719
  • Event Risk Class
    Class 2
  • Event Number
    Z-0584-2016
  • Event Initiated Date
    2015-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142027
  • 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, hemi-, femoral, metal - Product Code KWL
  • Reason
    The 16 devices distributed in the united states were incorrectly labeled as the monoblock birmingham hip modular head, with labeling not cleared for marketing in the us. the actual devices were monoblock modular femoral head for hemiarthroplasty use.
  • Action
    The firm sent their field safety notices on 11/16/2015 by letter delivered by Fed Ex (overnight) and email. Non- responding consignees will be contacted within 4 weeks of the initial notice

Device

Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD
  • Model / Serial
    All codes
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, France, UAE, Austria, Australia, Belgium, CANADA, Switzerland, Germany, Denmark, Spain, Finland, UK, Hong Kong, ISRAEL, India, Italy, Japan, South Korea, Netherlands, Norway, Poland, PORTUGAL, Sweden, SINGAPORE, Thailand, Turkey, and SOUTH AFRICA.
  • Product Description
    BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: || 74121238, MODULAR HEAD 38 MM -8MM || 74121242, MODULAR HEAD 42 MM -8MM || 74121246, MODULAR HEAD 46 MM -8MM || 74121250, MODULAR HEAD 50 MM -8MM || 74121254, MODULAR HEAD 54 MM -8MM || 74121258, MODULAR HEAD 58 MM -8MM || 74121338, MODULAR HEAD 3 8MM -4 (SHORT) || 74121342, MODULAR HEAD 42 MM -4 (SHORT) || 74121346, MODULAR HEAD 46 MM -4 (SHORT) || 74121350, MODULAR HEAD 50 MM -4 (SHORT) || 74121354, MODULAR HEAD 54 MM -4 (SHORT) || 74121358, MODULAR HEAD 58 MM -4 (SHORT) || 74121438, MODULAR HEAD 38 MM +0 (MED) || 74121442, MODULAR HEAD 42 MM +0 (MED) || 74121446, MODULAR HEAD 46 MM +0 (MED) || 74121450, MODULAR HEAD 50 MM +0 (MED) || 74121454, MODULAR HEAD 54 MM +0 (MED) || 74121458, MODULAR HEAD 58 MM +0 (MED) || 74121538, MODULAR HEAD 38 MM +4 (LONG) || 74121542, MODULAR HEAD 42 MM +4 (LONG) || 74121546, MODULAR HEAD 46 MM +4 (LONG) || 74121550, MODULAR HEAD 50 MM +4 (LONG) || 74121554, MODULAR HEAD 54 MM +4 (LONG) || 74121558, MODULAR HEAD 58 MM +4 (LONG)
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA