Events

Recall of Bearing Sleeve with Removable Bur Guard

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Anspach Effort, 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
    63793
  • Event Risk Class
    Class 2
  • Event Number
    Z-0783-2013
  • Event Initiated Date
    2012-09-05
  • Event Date Posted
    2013-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114783
  • 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
    Burr, Orthopedic - Product Code HTT
  • Reason
    Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. the materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.
  • Action
    The firm, Anspach Effort, Inc. sent an "URGENT: Medical Device Removal" letter dated November 7, 2012, to its customer. The letter identified the product, problem and actions to be taken. The customer was instructed to do the following: 1) Screen their inventory and remove and return all products immediately. 2) Complete and return the attached Customer Reply Form via fax or email to the address provided on the form. Should the customer have any questions, please contact Anspach Product Support at (800) 327-6887.

Device

Bearing Sleeve with Removable Bur Guard
  • Model / Serial
    Lot number: 2000930
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the state of Massachusetts
  • Product Description
    Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • Manufacturer Address
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA