Events

Recall of ConMed Linvatec 9263A 4.2mm Sterling, Blade, Gator Meniscus Cutter

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

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
    56441
  • Event Risk Class
    Class 2
  • Event Number
    Z-2503-2010
  • Event Initiated Date
    2010-08-05
  • Event Date Posted
    2010-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93673
  • 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
    Blade, Saw, General & Plastic Surgery, Surgical - Product Code GFA
  • Reason
    Conmed linvatec, largo, fl is recalling conmed linvatec 9263a,4.2mm sterling blade, gator meniscus cutter, lot number 178026 for breech in the sterile barrier.
  • Action
    Recall Notifications will be sent to all direct consignees by FedEx, email, Fax, etc. If the account no longer has the product in their possession, they will be asked to respond as such. A Return Material Authorizations Number will be assigned for the returned product as required. Product returned will be placed into quarantine and will be dispositioned in accordance with ConMed Linvatec procedures. 100% of the consignees will be contacted. The reply form is the mechanism to verify notification effectiveness to all consignees. If a reply is not received within approximately 30 business days of the first notification ConMed Linvatec will make two additional contacts by phone and / or email, as necessary, to insure all consignees have received notification and have taken appropriate action. If a reply is not received following the third contact by email or phone, no further contacts will be made to the consignee.

Device

ConMed Linvatec 9263A 4.2mm Sterling, Blade, Gator Meniscus Cutter
  • Model / Serial
    Lot 178026
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Products were distributed to ConMed Linvatec consignees, sales representatives and affiliates within the US and Australia. US distribution was to WA, AZ, PA, KS, NM, UT, ID, IL. Products were distributed to ConMed Linvatec Australia.
  • Product Description
    GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • Manufacturer Address
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA