Events

Recall of UniCP Compression Forceps (spreader)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp.

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
    49561
  • Event Risk Class
    Class 2
  • Event Number
    Z-0307-2009
  • Event Date Posted
    2008-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73813
  • 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
    Bone Fixation Plate - Product Code HRS
  • Reason
    Reports of the uni-cp compression forceps breaking during the compression of the uni-cp plate.
  • Action
    Recall Notice letters were sent to all Integra Sales Specialists on September 30, 2008 by first class mail. The letter informed them of the product and the problem concerning the product. The Sales Specialists were asked to return all inventories under their control with part number 339001ND from lots E6WS, E7UY, & E86M. They are required to fill out the attached form identifying the lot number for all Newdeal Compression Forceps (Spreader) in their inventory along with the serial number(s) of their Uni-CP set(s). The form should be filled out even if the sales specialist does not have a Uni-CP. The form should be faxed or mailed back to Walt Ryan in Customer Service, 609-799-3297. A RMA number will be generated for the return of any affected inventory. A replacement will be sent and upon receipt, the forceps (spreader) should be replaced and returned to the address indicated on the letter.

Device

UniCP Compression Forceps (spreader)
  • Model / Serial
    Lot numbers E6WS, E7UY and E86M.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Uni-CP Compression Forceps (spreader); || Non-sterile, R only, Catalog number: 339001ND || Newdeal, Lyon, France; || Integra, 411 Enterprise Drive, Plainsboro, NJ 08536 || Intended to open the UNI-Compression Plate olive, which creates a compression.
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp