Events

Recall of Device Recall ACUDRIVER

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
    26818
  • Event Risk Class
    Class 2
  • Event Number
    Z-0105-04
  • Event Initiated Date
    2003-06-17
  • Event Date Posted
    2003-11-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28511
  • 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
    Instrument, Cutting, Orthopedic - Product Code HTZ
  • Reason
    Instrument is excessively flexible making it unusable by the surgeon.
  • Action
    The firm mailed a Recall Notification Letter to each account on June 17, 2003 asking them to cease distribution, return recalled product to them and to subrecall to any accounts they may have distributed to.

Device

Device Recall ACUDRIVER
  • Model / Serial
    Lot 432978 Serial Numbers 0460912 to 0460954 Lot 433954 Serial Numbers 0471589 to 0482514 Lot 434846 Serial Numbers 0482490-0482514
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to five distributors in the following states: LA, ME, NV, and GA.
  • Product Description
    Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14
  • Manufacturer
    Exactech, Inc.

Manufacturer

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