Events

Recall of Device Recall R3 Forte Ceramic Liners

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
    58324
  • Event Risk Class
    Class 2
  • Event Number
    Z-2053-2011
  • Event Initiated Date
    2011-03-11
  • Event Date Posted
    2011-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98986
  • 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
    liner - Product Code MRA
  • Reason
    During the manufacturing process for several batches of r3 ceramic liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. this has the potential to result in lower than expected strength for the liners.
  • Action
    All affected Smith & Nephew Distributors were notified via email and the hospitals were notified by letter delivered by Fed-Ex on 3/11/2011. They were instructed to immediately cease distribution, quarantine affected product for return, if product further distributed, identify customers and immediately notify them of recall. Please contact Mr. David Archer, Group Director, at 701.396.2121, ext. 5373, if you have questions.

Device

Device Recall R3 Forte Ceramic Liners
  • Model / Serial
    09ET31294, 09FT32646M 09FT32802, 09FT32803, and 09FT33252
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI
  • Product Description
    R3 TM CERAMIC ACETABULAR LINER, BIOLOX¿ FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 || Usage: Primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis or traumatic arthritis
  • 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