Events

Recall of Device Recall Femoral component

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-1378-2013
  • 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=116554
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • 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 Femoral component
  • Model / Serial
    Catalog No. 2103-1310 2103-1320 2103-1330 2103-1340 2103-1350 2103-1360 2103-1410 2103-1420 2103-1430 2103-1440 2103-1450 2103-1460 2103-3110 2103-3120 2103-3130 2103-3140 2103-3150 2103-3160 2103-3210 2103-3220 2103-3230 2103-3240 2103-3250 2103-3260
  • 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
    Femoral component, CR, cemented, #1, left 2103-1310 || Femoral component, CR, cemented, #2, left 2103-1320 || Femoral component, CR, cemented, #3, left 2103-1330 || Femoral component, CR, cemented, #4, left 2103-1340 || Femoral component, CR, cemented, #5, left 2103-1350 || Femoral component, CR, cemented, #6, left 2103-1360 || Femoral component, CR, cemented, #1, right 2103-1410 || Femoral component, CR, cemented, #2, right 2103-1420 || Femoral component, CR, cemented, #3, right 2103-1430 || Femoral component, CR, cemented, #4, right 2103-1440 || Femoral component, CR, cemented, #5, right 2103-1450 || Femoral component, CR, cemented, #6, right 2103-1460 || Femoral component, PS, #1, left 2103-3110 || Femoral component, PS, #2, left 2103-3120 || Femoral component, PS, #3, left 2103-3130 || Femoral component, PS, #4, left 2103-3140 || Femoral component, PS, #5, left 2103-3150 || Femoral component, PS, #6, left 2103-3160 || Femoral component,PS, #1, right 2103-3210 || Femoral component,PS, #2, right 2103-3220 || Femoral component,PS, #3, right 2103-3230 || Femoral component,PS, #4, right 2103-3240 || Femoral component,PS, #5, right 2103-3250 || Femoral component,PS, #6, right 2103-3260 || 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