Events

Recall of LACTOSORB SYSTEM 2.0MM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet Microfixation, 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
    53845
  • Event Risk Class
    Class 2
  • Event Number
    Z-0489-2010
  • Event Initiated Date
    2009-09-15
  • Event Date Posted
    2010-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86663
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    Biomet microfixation is recalling lactosorb self drilling adjustable tap model numbers 915-2075 lot # 064350 and 915-2185 lot # 885580. the two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. depending on the tap (1.5mm vs 2.0mm) you may drill too shallow or too deep.
  • Action
    Biomet Microfixation notified consignees of the recalled product beginning September 2009 via telephone and e-mail correspondence. Users were asked to return the affected product to the firm. For further information, contact Biomet Microfixation at 1-904-741-9468.

Device

LACTOSORB SYSTEM 2.0MM
  • Model / Serial
    Lot Number: 064350
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA - FL, MO, and KS; Foreign: Brazil and China.
  • Product Description
    LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT, || BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. || Lacto Sorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the Lacto SorbBulbs Handles or Power Drivers to advance the Tap into the bone.
  • Manufacturer
    Biomet Microfixation, Inc.

Manufacturer

Biomet Microfixation, Inc.
  • Manufacturer Address
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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