Events

Recall of Device Recall AcuMatch MSeries Straight and Curved Fluted Stem Segments.

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
    37788
  • Event Risk Class
    Class 2
  • Event Number
    Z-0916-2007
  • Event Initiated Date
    2006-07-21
  • Event Date Posted
    2007-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51535
  • 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
    Stem Segments - Product Code LPH
  • Reason
    The packaging was mislabeled: exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.
  • Action
    The consignees were contacted by fax and email (dated July 21, 2006) to inform them of the recall requesting return of product

Device

Device Recall AcuMatch MSeries Straight and Curved Fluted Stem Segments.
  • Model / Serial
    0797860, 0797861, 0797862, 0797857, 0797858, 0797859
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    World wide-Domestically distributed to one account in Alabama and internationally to Columbia and Australia.
  • Product Description
    AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44.
  • 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