Events

Recall of Optetrak Asymmetric HiFlex Posterior Stabilized Cemented Femorals, size 3

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

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
    69466
  • Event Risk Class
    Class 2
  • Event Number
    Z-0906-2015
  • Event Initiated Date
    2014-10-09
  • Event Date Posted
    2015-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130723
  • 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
    Mislabeled.
  • Action
    The firm, Exactech, sent an "Urgent Field Safety Notice" letter dated September 30, 2014 to its Consignees/customers by electronic mail on October 9, 2014. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately cease distribution or use of the products; extend information to your accounts that may have this product in their possession; verify whether you have any of the subject femoral components from the specified serial number ranges; complete and return the attached inventory RESPONSE FORM via fax to: 011 61 2 9638 0778 within 48 hrs of receipt of the notice, and contact your Exactech representative to confirm quantities at your location and arrangements for product return and inventory restocking. If you have any questions, contact Manager, Regulatory Affairs at 352-377-1140.

Device

Optetrak Asymmetric HiFlex Posterior Stabilized Cemented Femorals, size 3
  • Model / Serial
    Catalog #244-02-03, Serial # 2925147 - 2925194; Catalog #244-03-0, Serial #2925246 - 2925293.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
  • Product Description
    Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. || Usage:Femoral implants
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
    Exactech Inc
  • Source
    USFDA