Events

Recall of Device Recall Bold/INIClip

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
    36868
  • Event Risk Class
    Class 2
  • Event Number
    Z-0466-2007
  • Event Initiated Date
    2006-11-10
  • Event Date Posted
    2007-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49477
  • 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
    Drill Bit - Product Code HTW
  • Reason
    Incorrect drill length-cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the uni-clip staple.
  • Action
    An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.

Device

Device Recall Bold/INIClip
  • Model / Serial
    Model/Catalog number: 159004ND Lot Number: D2CJ/; D2CJ/1; D2PS; E0X4; E14K; E14L; E14M; E14N; E1KM; E1KN; E1X2; E24S; E2JS; E2LP.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide to distributors, hospitals and Integra Sales Reps.
  • Product Description
    BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.