Events

Recall of Ascension PIP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ascension Orthopedics, 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
    25056
  • Event Risk Class
    Class 3
  • Event Number
    Z-0549-03
  • Event Initiated Date
    2002-10-31
  • Event Date Posted
    2003-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25088
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code ---
  • Reason
    Brochures approved for international distribution only were distributed domestically.
  • Action
    The firm began to contact all US distributors on October 31, 2002 and all US sales representatives on November 1, 2002, by e-mail to inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.

Device

Ascension PIP
  • Model / Serial
    Removal domestically of literature Document: LC-04-207-001
  • Product Classification
    Orthopedic Devices
  • Distribution
    AL, AZ, NM, TX, FL, NJ, CA, IL, TN, MS, OH, KY, IN, MN, NY, OR, WA, CO, PA, UT, MO, OK, NC, SC, VA, MD, PA, MA, CT, VT, ME, ID, LA, WI, NE
  • Product Description
    Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. || The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005
  • Manufacturer
    Ascension Orthopedics, Inc

Manufacturer

Ascension Orthopedics, Inc
  • Manufacturer Address
    Ascension Orthopedics, Inc, 8200 Cameron Road, Ste C-140, Austin TX 78754-3832
  • Source
    USFDA