Events

Recall of Device Recall CURVTEK EYE NEEDLE, 12 MM LARGE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet, Inc..

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
    58241
  • Event Risk Class
    Class 2
  • Event Number
    Z-1903-2011
  • Event Initiated Date
    2011-03-10
  • Event Date Posted
    2011-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98788
  • 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
    Needle, suturing, disposable - Product Code GAB
  • Reason
    The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution.
  • Action
    The firm, BIOMET, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated March 10, 2011 to all customers. The letter described the product, problem and actions to be taken. The letter noted that -Use of a non-sterile Curvtek Eye Needle may lead to patient infection, possibly requiring a revision procedure. The customers were instructed to immediately locate, discontinue use of the product , remove the product from circulation and return the product to Biomet; carefully follow the instructions on the enclosed FAX BACK RESPONSE FORM; complete and return the response form via fax to 574-372-1683 prior to return of product; use priority carrier for shipment, and please confirm receipt of this notice by calling 800-348-9500, extension 3755 or 3756. The firm also informed physicians that had previously utilized the device to monitor patients for infection and provide treatment as appropriate. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8am to 5pm.

Device

Device Recall CURVTEK EYE NEEDLE, 12 MM LARGE
  • Model / Serial
    Part Number 906764, Lots 748580, 748730 and 932650.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: IN and KY; and countries of: Canada and The Netherlands.
  • Product Description
    REF 906764, CURVTEK EYE NEEDLE, 12 MM LARGE, STAINLESS STEEL GAMMA STERILIZED, PKG/3, BIOMET SPORTS MEDICINE, 56 EAST BELL DRIVE, P.O. BOX 587, WARSAW, IN 46581 USA, STERILE || After the Curvtek device is used to drill a "C" shaped tunnel through the patient's bone, the device is used to pass suture through the tunnel so that soft tissue may be tied down directly onto the bone.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA