Events

Recall of Device Recall Birmingham Hip Resurfacing Femoral 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
    80126
  • Event Risk Class
    Class 2
  • Event Number
    Z-2267-2018
  • Event Initiated Date
    2018-05-11
  • Event Date Posted
    2018-05-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164624
  • 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/metal, resurfacing - Product Code NXT
  • Reason
    The affected devices are manufactured to the same design specification as products intended for sale and use in the us but do not contain the fda approved labeling (i.E., ifu and patient information brochure). the affected devices were distributed in the us with the ifu intended for use outside of the us.
  • Action
    The firm initiated the recall by email and letter on 05/11/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew.

Device

Device Recall Birmingham Hip Resurfacing Femoral Head
  • Model / Serial
    (a) Size 58 mm, REF 74121158, Lot 16CW08945 (b) Size 56 mm, REF 74123156, Lot 16CW08246
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    OH, TX, CO, TN, MI, PA, NJ
  • Product Description
    Birmingham Hip Resurfacing Femoral Head: || (a) Size 58 mm, REF 74121158 || (b) Size 56 mm, REF 74123156
  • 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