Events

Recall of Device Recall FMP Xalt Acetabular Liner

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

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
    67468
  • Event Risk Class
    Class 2
  • Event Number
    Z-1130-2014
  • Event Initiated Date
    2014-02-07
  • Event Date Posted
    2014-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125512
  • 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, porous uncemented - Product Code LPH
  • Reason
    Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. the units labeled as model/catalog number 931-28-248 lot/serial number 685f1034 on the outside and containing model/catalog number 932-36-252, lot# 728f1089 on the inside (1.
  • Action
    DJO Global sent an Urgent Field Safety Notice dated February 7, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. All 10 devices with the outer label of 931-28-248, Lot#685F1034 were found in-house and were quarantined. The agencies who have the affected product (devices labeled as 932-36-252, Lot# 728F1089 containing 931-28-248, Lot#685F1034) were contacted to quarantine their devices. Of the affected devices, 2 of the lot of 10 have already been returned via product complaint. Customers were instructed to pass on the notice to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. Customers were instructed to place a replacement order and receive an RMA number to return all affected devices.. Customers with questions were instructed to call 512-834-6255.

Device

Device Recall FMP Xalt Acetabular Liner
  • Model / Serial
    Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner)  were mistakenly packaged/labeled as  Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner)  and vice-versa
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution - USA including TX, LA, FL, CA, and AZ.
  • Product Description
    FMP X-alt Acetabular Liner || This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
  • Manufacturer
    Djo Surgical

Manufacturer

Djo Surgical
  • Manufacturer Address
    Djo Surgical, 9800 Metric Blvd, Austin TX 78758-5445
  • Source
    USFDA