Events

Recall of Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK

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

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
    61038
  • Event Risk Class
    Class 2
  • Event Number
    Z-1003-2012
  • Event Initiated Date
    2012-01-10
  • Event Date Posted
    2012-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107151
  • 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
    Tray surgical - Product Code LRP
  • Reason
    The firm distributed surgical kits which contained dermahook neuro elastic retractors which were subsequently recalled by teleflex.
  • Action
    DeRoyal Industries sent a Customer letter dated January 6, 2012, to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. An email was also sent on January 10, 2012, to the affected customer. The customer was requested to follow these instructions. 1) Identify any affected inventory using the product and lot numbers on Attachment 1. 2) Attach the provided warning label to each affected kit and tray. 3) Forward this recall to any of your end users that may have affected product. 4) Complete and return Attachment 1 by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter, even if you no longer have affected inventory. If you have questions or need assistance with the recall, including additional labels, please call (865) 362-1037 . We apologize for any inconvenience this may caused you.

Device

Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK
  • Model / Serial
    REF 89-7639.01 - Lot Number 24579045  REF 89-7639.01 - Lot Number 24664258  REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    (USA) including Indiana
  • Product Description
    Custom surgical kits: || DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || surgical kits
  • Manufacturer
    DeRoyal Processing Center

Manufacturer

DeRoyal Processing Center
  • Manufacturer Address
    DeRoyal Processing Center, 1703 Highway 33 S, New Tazewell TN 37825-5043
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA