Events

Recall of Device Recall UniCP Compression Plate System

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
    57380
  • Event Risk Class
    Class 2
  • Event Number
    Z-0955-2011
  • Event Initiated Date
    2010-11-18
  • Event Date Posted
    2011-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96421
  • 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
    Plate, fixation, bone - Product Code HRS
  • Reason
    Integra lifesciences corporation has decided to initiate a voluntary recall of the uni-comp kits due to inaccurate information relative to the recommended sterilization parameters described in the products instructions for use (ifu). the sterilization parameters noted in the uni-comp ifu were incorrect. it is noted that the sterilization recommendations in the uni-comp ifu in which the exposure.
  • Action
    The firm, Integra, contacted the Sales Representatives on November 8, 2010 via telephone conference calls. Integra also sent a "URGENT: PRODUCT RECALL NOTIFICATION" letter dated November 9, 2010 all customers via FedEx overnight delivery. The letter described the product, problem and the action to be taken by the customers and the firm. The customers were instructed to immediately examine their inventory, QUARANTINE THE PRODUCT, and complete and return the RECALL ACKNOWLEDGMENT AND RETURN FORM via mail: Integra LifeSciences Corporation, Attn: Sandy Yates, 311 Enterprise Drive, Plainsboro, NJ 08536, fax to (609)-275-5363 or Scan and email to sandra.yates@integralife.com. The firm will have a Integra LifeSciences Corporation Sales Representative contact the customer to assist them in retrieving and returning their Uni-CP Compression Plate System to Integra. Integra will also ship replacement Uni-CP Compression Plate (Uni-CPII and Large Uni-Clip) Systems back to the customers as soon as possible at no charge. Should you have any additional questions, contact the Director of Marketing, Hindfoot-Extremity Reconstruction or your regional managers at 513-533-7929, 609-275-0500 or toll free at 800-654-2873.

Device

Device Recall UniCP Compression Plate System
  • Model / Serial
    Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.
  • Product Description
    Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC || The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.