Events

Recall of Device Recall PolyAx Locking Plate System

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
    57396
  • Event Risk Class
    Class 2
  • Event Number
    Z-1579-2011
  • Event Initiated Date
    2010-11-01
  • Event Date Posted
    2011-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96039
  • 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
    Bone Fixation Plate - Product Code HRS
  • Reason
    The firm determined that the 8.0 mm hole threads in the polyax distal femoral locking plate were incorrectly manufactured, which prevents the mating screw from locking in place. the screw should lock with the plate, instead the screw passes through the plate.
  • Action
    Urgent Information - Recall Notice letters, dated November 1, 2010 were sent to customers. The letters described the reason for recall and identified the product affected along with the affected units. The letters also provided clinical guidance and stated that the problem had been corrected and that DePuy was in the process of replenishing its inventory. Hospitals were to determine if any of the recalled components they received were still on hand, and return them immediately to their DePuy Representative or directly to DePuy for credit.

Device

Device Recall PolyAx Locking Plate System
  • Model / Serial
    DLHBTN, DLIB43.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- ME, MA, FL, VA, CO, TX, WY, AZ, MO, WI, GA, PA, AL, NY, OH, NJ, NC, and CA.
  • Product Description
    PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 12 hole, Sterile, REF 8141-30-112, Depuy Orthopaedics, Inc., Warsaw, IN.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

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