Events

Recall of Device Recall Anspach BLACKMAXN (Pneumatic motor) and Autolube III

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
    67131
  • Event Risk Class
    Class 2
  • Event Number
    Z-0631-2014
  • Event Initiated Date
    2012-06-11
  • Event Date Posted
    2014-01-06
  • 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=124751
  • 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
    Motor, surgical instrument, ac-powered - Product Code GEY
  • Reason
    Anspach was contacted by a hospital to inform anspach that a blackmax motor had been used in a case where the patient was diagnosed with creutzfeldt-jacob disease (cjd).
  • Action
    none

Device

Device Recall Anspach BLACKMAXN (Pneumatic motor) and Autolube III
  • Model / Serial
    Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution: Maryland only.
  • Product Description
    Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). || Cutting and shaping bone.
  • 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