Events

Recall of Device Recall ARTHROKNIFE

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
    54701
  • Event Risk Class
    Class 2
  • Event Number
    Z-2258-2010
  • Event Initiated Date
    2010-01-28
  • Event Date Posted
    2010-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92987
  • 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
    Arthroscope - Product Code HRX
  • Reason
    This recall was due to the possibility that multiple products may have a breach in the poly-tyvek pouch that could potentially compromise the sterility of the contents.
  • Action
    Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.

Device

Device Recall ARTHROKNIFE
  • Model / Serial
    Lot Number: 15870,  83883,  84154,  84153,  84152,  92235,  92237,  92236,  92234,  92231,  92232,  92233,  103605,  103602,  103604,  103608,  103607,  103606,  107423,  107425,  109060,  109061,  109062, and  110940.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, South Africa, and throughout the U.S.
  • Product Description
    REF 70-0074-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, ROSETTE, SERRATED, STRAIGHT, STERILE, Rx ONLY. || CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. || Intended for use in orthaepedic surgery where a cutting instrument is required.
  • 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