Recall of Device Recall CREAMER

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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Reason
    This recall was due to the possibility that the 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.


  • Model / Serial
    Lot Number: REF 8772A - 46688,  73871,  73870,  73869,  87154,  86536,  87153,  86537,  98292,  98291,  111143,  111144,  112911,  112912,  116059.   REF 8773A - 65279,  65280,  65278,  83399,  83400,  88699,  88698,  101187,  98663,  101186,  112011,  113322,  121931.   REF 8774A - 65265,  65264,  65266,  87162,  91944,  102320,  101157,  113329.   REF 8775A - 46684,  73851,  73852,  91942,  96125,  96126,  101183, and  102325.
  • Product Classification
  • Device Class
  • Implanted device?
  • 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
    C-REAMER CANNULATED, STERILE, Rx ONLY. || REF 8772A, 9.0MM, QTY DIST 712. || REF 8773A, 10MM, QTY DIST 1,244. || REF 8774A, 11MM, QTY DIST 384 || REF 8775A, 12MM, QTY DIST 156 || CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
  • Manufacturer


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