Events

Recall of Device Recall DePuy ASR 100 Acetabular Implant, 46 mm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Depuy Orthopaedics, 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
    55575
  • Event Risk Class
    Class 2
  • Event Number
    Z-2032-2010
  • Event Initiated Date
    2010-03-05
  • Event Date Posted
    2010-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91220
  • 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 uncemented acetabular component) - Product Code KWA
  • Reason
    Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
  • Action
    DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.

Device

Device Recall DePuy ASR 100 Acetabular Implant, 46 mm
  • Model / Serial
    1133049, 1875469, 1959229, 1959230, 1959231, 1959232, 1959233, 1959234, 1959235, 1959236, 2061753, 2061754, 2061755, 2061756, 2081397, 2081398, 2081399, 2081400, 2112725, 2112726, 2125121, 2125122, 2139978, 2139979, 2139980, 2156769, 2158469, 2158470, 2165150, 2165151, 2165152, 2165155, 2174121, 2174122, 2174123, 2174124, 2177983, 2177984, 2177985, 2190320, 2190321, 2190322, 2190323, 2204648, 2209316, 2209317, 2209318, 2209319, 2209320, 2309670, 2309671, 2309672, 2332051, 2332052, 2354505, 2354506, 2363963, 2382339, 2382340, 2407764, 2407765, 2407766, 2407767, 2407768, 2436280, 2436281, 2436282, 2436283, 2446689, 2446690, 2459082, 2459083, 2470024, 2470025, 2470026, 2470027, 2470028, 2541789, 2541790, 2541791, 2541792, 2546335, 2546338, 2576763, 2576764, 2576765, 2585100, 2585101, 2588587, 2588588, 2602544, 2641373, 2641373, 2641374, 2650304, 2650305, 2650306, 2675583, 2678720, 2743860, 2743861, 2748475, 2748476, 2748477, 2748478, 2748479, 2802476, 2826560, 2826561, 2841194, 2858967 and Y5CHN1000.
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    DePuy ASR 100 Acetabular Implant, 46 mm, 999800746, sterile, DePuy International, Ltd, Leeds, United Kingdom.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • Manufacturer Address
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA