Events

Recall of Device Recall CrossFT Suture Anchor with Two 2 HiFi Sutures

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
    58936
  • Event Risk Class
    Class 2
  • Event Number
    Z-2703-2011
  • Event Initiated Date
    2011-01-26
  • Event Date Posted
    2011-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100643
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Reason
    Conmed linvatec, largo, fl is recalling crossft suture anchor with two #2 hi-fi sutures, lot 211581, product number cfp-5502. there is a possibility that the product may have been incorrectly assembled. the disposable driver may have the incorrect color handle (red versus black).
  • Action
    ConMed Linvatec sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated January 27, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to check their inventory for affected lots and return for credit. A Reply Form and FedEx Air bill was enclosed with the letter for customers to complete and return with the product. Questions regarding the recall can be answered by contacting the Customer Service Department via e-mail at Custserv1@linvatec.com.

Device

Device Recall CrossFT Suture Anchor with Two 2 HiFi Sutures
  • Model / Serial
    Lot 211581
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution--USA (nationwide) and countries of Canada and South Africa.
  • Product Description
    "***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERILE EO***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA Made in USA***REF CFP-5502***" || The non absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
  • 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