Events

Recall of Device Recall Surgical Blade

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
    58013
  • Event Risk Class
    Class 2
  • Event Number
    Z-1880-2011
  • Event Initiated Date
    2010-11-30
  • Event Date Posted
    2011-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97969
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Reason
    On nov 30, 2010 conmed linvatec, largo, fl recalled their micro sagittal blade, fine lot number 180209, product number 5023-138. some units of micro sagittal blade, fine from lot 180209 may have compromised seals in the sterile packaging.
  • Action
    Linvatec Corp. dba ConMed sent an Urgent Medical Device Recall Notification letter dated November 30, 2010, by FedEx, email, Fax, etc) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the reply form within 30 days of receipt. Immediately check their facility's inventory for the affected product and lot number. If they had any of the product with lot number 180209. Do Not Use. Segregate and return for credit. If the product was transferred to another facility, customers were to complete the REPLY FORM documenting the transfer of the product and fax the form to 727-319-5701. For questions regarding this recall call 727-319-5701 or 800-535-8536.

Device

Device Recall Surgical Blade
  • Model / Serial
    Lot: 180209
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CT, FL, GA, HI, IN, MO, MS, MT, NJ, NY, OH, PA, SC, and TX and the countries of Canada, and South Africa.
  • Product Description
    POUCH/CARTON LABEL: || ***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Made in USA*** || To cut soft tissue or bone
  • 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