Events

Recall of Device Recall 87k Arthroscopy Tubing Set

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
    56163
  • Event Risk Class
    Class 2
  • Event Number
    Z-2192-2010
  • Event Initiated Date
    2010-07-06
  • Event Date Posted
    2010-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92773
  • 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
    Conmed linvatec largo, fl is recalling 87k arthroscopy tubing set, product number 87100, lots 0904151 to and including 1005201. product may have a breach in the seal that could potentially compromise the sterility of the contents.
  • Action
    ConMed Linvatec Corporation sent an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 6, 2010, via FedEx next day delivery to all customers. The letter described the product, problem and action to be taken by customers within 30 days of receipt of the letter. The customers were asked to PLEASE DISCONTINUE USE OF THE IDENTIFIED PRODUCT WITH LOT NUMBERS BEGINNING WITH 0904151 THROUGH AND INCLUDING 1005201; to immediately check their inventory for the affected lots number and Do Not Use if they have any of the products; to complete and return a Reply Form and to notify their customers if the product was further distributed and return all unused affected product with lot codes starting 0904151 to and including 1005201, to ConMed Corporation, 525 French Road, Utica, NY 13502. On receipt, ConMed Linvatec will issue credit to customers. Should you have any additional questions, please contact our Customer Service department at 800-535-8536 or fax at 727-319-5701 or email: Custerserv1@linvatec.com

Device

Device Recall 87k Arthroscopy Tubing Set
  • Model / Serial
    Lot 0904151 through 1005201.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and Canada.
  • Product Description
    REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set with any Small Joint Cannula System. || CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Made in USA. || The 87K Arthroscopy Tubing Set is designed for use with the 87K Arthroscopy Pump System. This system can be used in arthroscopic procedures using fluid irrigation for joint distension. This system may be used where gravity systems are currently in use such as knee, shoulder, ankle and elbow arthroscopy.
  • 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