Events

Recall of Device Recall Zimmer Most Hinged Tibia Baseplate Spacer

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
    51039
  • Event Risk Class
    Class 2
  • Event Number
    Z-0996-2009
  • Event Initiated Date
    2009-01-29
  • Event Date Posted
    2009-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78236
  • 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
    Knee Femorotibial Metal/Polymer Constrained Cemented Prosthesis - Product Code KRO
  • Reason
    The package contains 11 mm screws instead of the specified 6 mm screws.
  • Action
    The consignee in Germany was notified by an Urgent: Device Recall letter dated 1/29/09, and delivered by email on 2/19/09. The letter stated the reason for the recall and clinical implications. The firm asked the consignee to stop using the provisional and quarantine it immediately; physically count all affected product and record data on the Inventory Return Certification Form included with letter; fax a copy of the completed form to Zimmer, Inc at 574-371-8603; request an IRA from Lindsey Arnett; and return recalled product along with completed Inventory Return Certification Form and IRA to Simmer Distribution Center. The letter states that credit will be issued upon receipt of the returned product. Also, if product has been further distributed, a copy of the recall letter should be provided to the customers. Questions or assistance should be directed to Zimmer, Inc at 1-800-613-6131.

Device

Device Recall Zimmer Most Hinged Tibia Baseplate Spacer
  • Model / Serial
    Lot 1635572.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    International Distribution only -- Country of Germany.
  • Product Description
    Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001. || Component used to augment uni- and bi-compartmental defects and is manufactured from Ti-6A1-4V Alloy.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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