Events

Recall of 26.65CM ATTACHMENT, BLACK MAX

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
    76059
  • Event Risk Class
    Class 2
  • Event Number
    Z-1978-2017
  • Event Initiated Date
    2016-10-06
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152335
  • 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
    Table and attachments, operating-room - Product Code BWN
  • Reason
    Supplied directions for use (dfu) did not contain a recommended service interval.
  • Action
    Consignees were sent a recall notice via mail, dated 10/10/2016. In the notice, the firm notifies consignees of the Directions For Use (DFU) correction that will include recommended servicing intervals. All DFUs distributed after 09/28/2016 will have the correct DFU. The recalling firm instructs consignees to review the service intervals provided for product received, forward the notification to necessary parties and/or facilities, and complete the attached Verification Form. Complete Verification Forms are to be sent by fax to 877-546-5069 or by email to Anspach4870@stericycle.com. Consignees are also asked to maintain a copy of the notice for their records. Any questions can be directed to Customer Service at 1-800-327-6887, option 1.

Device

26.65CM ATTACHMENT, BLACK MAX
  • Model / Serial
    All serial numbers shipped to customers; DFU 18-0062; Part No. B-RED.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
  • Product Description
    26.65CM ATTACHMENT, BLACK MAX
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

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