Events

Recall of Device Recall Anspach MIA 16

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
    67179
  • Event Risk Class
    Class 2
  • Event Number
    Z-0779-2014
  • Event Initiated Date
    2013-05-06
  • Event Date Posted
    2014-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124879
  • 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
    Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
  • Reason
    Product did not reach expected sterility assurance level.
  • Action
    The firm, Aspach, sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated May 13, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/ customers were instructed that Sterrad 100S system should not be used on the MIA 16 attachment (the information only applies to only Sterrad sterilization of this devices and not to any other attachments.), and complete and return the Return Receipt Requested Customer Reply form via fax to: 1-800-327-6661 or email: ProductSupportTeam@synthes.com. If you distribute any of the products to other services or facilities, please forward this information as appropriate. Should you have any queries, please do not hesitated to contact Anspach Product Support at (800) 327-6887. Hours of Operation are 8:30am-5:30pm Eastern Standard Time or email: ProductSupportTeam@synthes.com.

Device

Device Recall Anspach MIA 16
  • Model / Serial
    ALL LOTS
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN.
  • Product Description
    Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only || MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, 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