Events

Recall of Device Recall ANTHOLOGY POROUS HIGH OFFSET STEM

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
    80050
  • Event Risk Class
    Class 2
  • Event Number
    Z-1921-2018
  • Event Initiated Date
    2018-05-02
  • Event Date Posted
    2018-05-09
  • 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=164289
  • 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, cemented - Product Code JDI
  • Reason
    Three lots of anthology ho porous size 7 stems were manufactured with an undersized taper length. the device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
  • Action
    The firm initiated the recall by letter on 05/02/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out. For further questions, please call (978) 749-1440

Device

Device Recall ANTHOLOGY POROUS HIGH OFFSET STEM
  • Model / Serial
    Lot Numbers: 17LM22019, 17LM10934, 17LM05900
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution.
  • Product Description
    smith&nephew; ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
  • 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