Events

Recall of Device Recall U2 Acetabular cup

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

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
    64588
  • Event Risk Class
    Class 2
  • Event Number
    Z-1381-2013
  • Event Initiated Date
    2013-02-20
  • Event Date Posted
    2013-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118173
  • 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
    The recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
  • Action
    A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

Device

Device Recall U2 Acetabular cup
  • Model / Serial
    Item No. 1303-5444 1303-5446 1303-5448 1303-5450 1303-5452 1303-5454 1303-5456 1303-5458 1303-5460 1303-5462 1403-1044 1403-1046 1403-1048 1403-1250 1403-1252 1403-1654 1403-1656 1403-1658 1403-1660 1403-1662
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
  • Product Description
    U2 Acetabular cup, Ti beads porous coated, ¿44mm || U2 Acetabular cup, Ti beads porous coated, ¿46mm || U2 Acetabular cup, Ti beads porous coated, ¿48mm || U2 Acetabular cup, Ti beads porous coated, ¿50mm || U2 Acetabular cup, Ti beads porous coated, ¿52mm || U2 Acetabular cup, Ti beads porous coated, ¿54mm || U2 Acetabular cup, Ti beads porous coated, ¿56mm || U2 Acetabular cup, Ti beads porous coated, ¿58mm || U2 Acetabular cup, Ti beads porous coated, ¿60mm || U2 Acetabular cup, Ti beads porous coated, ¿62mm || U2 Acetabular cup liner assembly, 10¿hooded,44mm || U2 Acetabular cup liner assembly, 10¿hooded,46mm || U2 Acetabular cup liner assembly, 10¿hooded,48mm || U2 Acetabular cup liner assembly, 10¿hooded,50mm || U2 Acetabular cup liner assembly, 10¿hooded,52mm || U2 Acetabular cup liner assembly, 10¿hooded,54mm || U2 Acetabular cup liner assembly, 10¿hooded,56mm || U2 Acetabular cup liner assembly, 10¿hooded,58mm || U2 Acetabular cup liner assembly, 10¿hooded,60mm || U2 Acetabular cup liner assembly, 10¿hooded,62mm || Variety of hip and knee implants and instruments, multiple uses.
  • Manufacturer
    Orthopedic Alliance LLC

Manufacturer

Orthopedic Alliance LLC
  • Manufacturer Address
    Orthopedic Alliance LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
  • Source
    USFDA