Events

Recall of Device Recall Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle

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
    50552
  • Event Risk Class
    Class 2
  • Event Number
    Z-0990-2009
  • Event Initiated Date
    2008-12-19
  • Event Date Posted
    2009-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75746
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The c-clip located near the connection end may fracture or fall off during use in surgical procedures.
  • Action
    U.S. consignees were notified by "Urgent: Device Recall" letter issued via e-mail on December 19, 2008. The letter described the problem and instructed customers to immediately quarantine and return the recalled product along with the completed Inventory Return Certification form to the Zimmer, Inc. Distribution Center. Consignees were also instructed to fax a copy of the completed Inventory Return Certification Form at 1-574-371-8603. International consignees were also notified, but Zimmer, Inc. will gather the instruments from those customers. Direct questions about the recall to Zimmer, Inc. at 1-800-613-6131.

Device

Device Recall Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle
  • Model / Serial
    Lot Numbers: 08701500, 60244766, 60254447, 60277967, 60289960, 60293969, 60313973, 60321519, 60331048, 60353723, 60360727, 60380526, 60406615, 60407562, 60422090, 60423663, 60454975, 60517608, 60685054, 60812396 and 60813212.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA, Belgium, Czech Republic, Finland, Germany, Greece, Italy, Poland, Romania, Spain and United Kingdom.
  • Product Description
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-01. || The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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