Events

Recall of Exactech

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
    26919
  • Event Risk Class
    Class 3
  • Event Number
    Z-1211-03
  • Event Initiated Date
    2003-08-01
  • Event Date Posted
    2003-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28747
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Reason
    Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. the misalignment of the pin fixation holes only creates an issue when augmentation is used.
  • Action
    A recall letter dated July 31, 2003, requesting return of certain Tibial Augmentation Block Trials and an advisory (Field Advisory K-078) on the use of certain Tibial Tray Trials and Trapezoid Tibial Tray Trials. The recall letter gives the address to return product as: Exactech, 2243 NW 66th Court, Gainesville, FL. Consignees were told to immediately cease distribution or use of the recalled products and to return them. Also the letter asks them to extend the recall information to their user accounts and to read and comply with the instructions provided in the attached 'Field Advisory K-078'. This advisory instructs the dealers and users on the use of the devices to avoid problems.

Device

Exactech
  • Model / Serial
    Tibial Augment block Trial, Catalog # 205-60-05, Lot #''s 4786-001 and 6509-001 Tibial Augment Block Trial, Catalog # 205-60-08 Lot #''s 4786-002 and 6509-002 Tibial Tray Trial, Catalog # 201-70-81, Lot #''s 4580-002, 6449-002 & 09861014 Trapezoid Tray Trial, Catalog # 205-70-81, Lot #''s 4603-002 & 6449-013
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. Also the products were distributed to three intenational accounts in Spain, Japan and China.
  • Product Description
    Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta and Exactech Trapezoid Tray Trial size 1 Delta.
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Manufacturer Address
    Exactech, Inc., 2320 N.W. 66th Court, Gainesville FL 32653
  • Source
    USFDA