Events

Recall of Device Recall Biomet Microfixation, Inc. Obwegeser Ramus Clamp

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
    50737
  • Event Risk Class
    Class 3
  • Event Number
    Z-0906-2009
  • Event Initiated Date
    2008-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76778
  • 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
    Self Retaining Clamp - Product Code EMG
  • Reason
    The biomet microfixation obwegeser ramus clamp, wide right 01-7996 were incorrectly etched as the left part number 01-7997.
  • Action
    Customers were contacted by e-mail notification with read receipt. Customers were notified in the e-mail to immediately discontinue use of the recalled product and return the affected items to Biomet Microfixation, Inc. The e-mail also included an Inventory Reconciliation form for customers to complete and return via fax (904-741-1801) to Biomet Microfixation, Inc. For questions related to this notice, please call 1-800-874-7711 or 904-741-4400 extension 448, Monday through Friday, 8 a.m.-4 p.m. Eastern Standard Time (EST).

Device

Device Recall Biomet Microfixation, Inc. Obwegeser Ramus Clamp
  • Model / Serial
    Lot Number 050801.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    International Distribution including countries of Ireland and Japan.
  • Product Description
    Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. Walter Lorenz Surgical, Inc., Subsidiary of Biomet Microfixation, Inc. NOTE: None distributed domestically. || Cranio-maxillofacial manual instrumentation to be used to aid in the treatment and care of patients, as determined appropriate, by a trained medical professional. The Obwegeser Ramus Clamps are self-retaining clamps, used on the ascending ramus of the mandible with an extension on one of the blades (shields) to aid in retracting the soft tissue of the cheek.
  • 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