Events

Recall of Device Recall REF L3SD 3 mm Diamond Ball, Standard Length

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
    68109
  • Event Risk Class
    Class 2
  • Event Number
    Z-1574-2014
  • Event Initiated Date
    2014-01-08
  • Event Date Posted
    2014-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126952
  • 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
    Anspach product code l-3sd contained product code s-3sd which is shorter in length than the labeled product.
  • Action
    Anspach sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated January 13, 2014, to all affected customers. The letter described the product, the problem and actions to be taken. If they have distributed any of the products to other services or facilities, customers were instructed to please forward this information as appropriate. Customers with questions you contact Anspach Customer Support at (800) 327-6887, option 3 or email customer.support@synthes.com.. Customers were asked to complete the attached reply form confirm receipt of the letter, return the completed form by fax to 800-327-6661. For questions regarding this recall call 561-494-3706.

Device

Device Recall REF L3SD 3 mm Diamond Ball, Standard Length
  • Model / Serial
    Lot/Set/Serial: G323081803.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including FL, TX, NC, IL, CO, and PA.
  • Product Description
    ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
  • 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