Events

Recall of Device Recall LIMA Modular Revision Hip Stem

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
    76209
  • Event Risk Class
    Class 2
  • Event Number
    Z-1191-2017
  • Event Initiated Date
    2017-01-10
  • Event Date Posted
    2017-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152523
  • 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
    Lima proximal bodies were inadvertently re-sterilized. the safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from uhmwpe, which is not approved for repeated gamma sterilization.
  • Action
    DJO Global sent an Urgent Field Safety Notice letter dated January 10, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the Acknowledgement and receipt Form. Customers were instructed to contact Customer Service at 1-800-456-8696 to explore options for a replacement order.

Device

Device Recall LIMA Modular Revision Hip Stem
  • Model / Serial
    1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
  • Product Description
    LIMA Modular Revision Hip Stem Model 428-01-050_110 || Product Usage: || The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
  • Manufacturer Parent Company (2017)
    The Blackstone Group LP
  • Source
    USFDA