Events

Recall of Device Recall CLP Instrumentation Removal Hook

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encore Medical, Lp.

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
    57286
  • Event Risk Class
    Class 2
  • Event Number
    Z-0828-2011
  • Event Initiated Date
    2010-11-10
  • Event Date Posted
    2010-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95742
  • 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
    Extractor - Product Code HWB
  • Reason
    Revision a and b clp extraction hooks may fracture at the distal end, resulting in surgical delay.
  • Action
    DJO issued an Urgent Recall Notice letter dated November 10, 2010 to consignees identifying the affected devices and requesting return of all affected devices for replacement. Customers are also requested to complete and return an enclosed Recall Response Form. Customers can contact David Harris of DJO at 512 834-6330 with questions about this recall.

Device

Device Recall CLP Instrumentation Removal Hook
  • Model / Serial
    Device Listing Number: A776463. Device Part Number: 803-08-033. Lot/Serial Numbers: 34596L02, 32503L02, 32503L01(B)
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the states of AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI.
  • Product Description
    CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA