Recall of Surgical Bit

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Bit, drill - Product Code HTW
  • Reason
    Linvatec corporation dba conmed linvatec in largo, fl is recalling the s8580, 8.0mm sentinel cannulated drill bit, lot numbers 322225 and 322226; and the s8585, 8.5mm sentinel cannulated drill bit, lot number 322287. recall was initiated due to the incorrect labeling on package.
  • Action
    ConMed/Linvatec sent an Urgent Medical Device Recall Notificaiton letter via phone and FedEx on April 9, 2012 and again on May 11, 2012, to all affected customers. They also sent the same Notification on May 14, 2012, to international accounts. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete a reply formand fax it to 727-319-5701. Customers were also instructed to return all affected product to the firm. All returned product under this removal action will be identified, segregated and quarantined per firm procedures, etc. Customers with questions should contact Customers Service at For questions regarding this recall call 727-392-6464.


  • Model / Serial
    S8580 (8.0MM Drill Bit), lot numbers 322225 and 322226
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
  • Product Description
    "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". || This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
  • Manufacturer


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