Events

Recall of Device Recall Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    55119
  • Event Risk Class
    Class 2
  • Event Number
    Z-0493-2011
  • Event Initiated Date
    2010-02-16
  • Event Date Posted
    2010-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89981
  • 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
    Instrument, compression - Product Code HWN
  • Reason
    The firm determined that the recalled instruments were manufactured using the wrong grade of material. as manufactured, the instruments are more brittle, increasing the potential for fracture.
  • Action
    Zimmer sent an Urgent Device Recall letter dated February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to monitor all potentially affected patients through regular office consultations. Ensure Zimmer Reconstruction System Tenaculum System Instrument Users at their facility were informed of the urgent device recall. Locate all instruments and quarantine them immediately. Count all affected product in their territory and record the data on the Inventory Return Certification Form included with the letter. Fax a copy of the completed Inventory Return Form to: Zimmer, Inc. at (574) 372-4265. Return the recalled product along with the original completed Inventory Return Certification Form to: Zimmer Distribution Center Attn: Product Service 1777 West Center Street Warsaw, IN 46580 For questions customers were instructed to contact their Zimmer Sales Representative. For questions regarding this recall call 1 - (800) 613-6131.

Device

Device Recall Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch
  • Model / Serial
    lot # 60869302 and lot # 60963801
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Product Description
    Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA