Events

Recall of Device Recall ConMed Linvatech Hall Surgical Blades, Sterile ST STERNUM SAW BLADES

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

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
    47848
  • Event Risk Class
    Class 2
  • Event Number
    Z-0400-2009
  • Event Initiated Date
    2008-02-21
  • Event Date Posted
    2009-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70467
  • 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
    Surgical Instrument Motors and Accessories/Attachments - Product Code GET
  • Reason
    Sterility compromised. there is a possibility that certain catalog number and lots of conmed linvatec hall surgical blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
  • Action
    An Urgent Medical Device Recall letter was issued. Customers must check their facility's inventory immediately for the catalog and lot numbers in the attached list. They also need to complete and sign the enclosed Reply Form and mail or fax the Reply Form to ConMed Linvatec using the enclosed self addressed postage paid envelope or fax 727-319-5701. Customers have an option to either re-sterilize the products using the re-sterilization instructions in the letter or they can return the devices to ConMed Linvatec for a credit using the enclosed preprinted FedEx Air Bill with ConMed Linvatec's Bill Number and the return goods number. Recall is being conducted to the distributor and end user level.

Device

Device Recall ConMed Linvatech Hall Surgical Blades, Sterile ST STERNUM SAW BLADES
  • Model / Serial
    BBD42852, BBD43151, BBD43382, BBD22173, BBD22174, BBD24764, BBD25349, BBD25350, BBD25351, BBD25528, BBD26280, BBD26281, BBD27083 through BBD27085, BBD33998 through BBD34001, BBD34078, BBD34286, BBD35717, BBD36143, BBD37689, BBD37690, BBD37691, BBD39468, BBD41576 through BBD41578, and BBD42027.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    ConMed Linvatec Hall Surgical Blades, Sterile ST STERNUM SAW BLADES, Catalog # 00505953200 || ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
  • Manufacturer
    Linvatec Corp.

Manufacturer

Linvatec Corp.
  • Manufacturer Address
    Linvatec Corp., 11311 Concept Boulevard, Largo FL 33773
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA