Events

Recall of Device Recall Integra Leyla Ball Joint Clamp

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

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
    65824
  • Event Risk Class
    Class 2
  • Event Number
    Z-2056-2013
  • Event Initiated Date
    2013-07-17
  • Event Date Posted
    2013-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120309
  • 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
    Drills, burrs, trephines & accessories (manual - Product Code HBG
  • Reason
    As a result of complaint investigations it was identified that there is a potential that the leyla ball joint clamp (r2383) may not provide the level of stability needed to maintain retraction in all cases.
  • Action
    Integra sent an Urgent Medical Device letter dated July 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to review your inventory and determine if you have any of the affected products. If so, stop using them immediately and remove them from your service. When your form is received, Customer Service will you an RMA number and directions for returning the products. Should you have any questions regarding these instructions, please contact Integra Customer Service at 1-800-997-4868.

Device

Device Recall Integra Leyla Ball Joint Clamp
  • Model / Serial
    Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.
  • Product Description
    Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. || The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
  • Manufacturer
    Integra Limited

Manufacturer

Integra Limited
  • Manufacturer Address
    Integra Limited, 311 Enterprise Dr, Plainsboro NJ 08536-3344
  • Source
    USFDA