Events

Recall of Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set

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

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
    56894
  • Event Risk Class
    Class 2
  • Event Number
    Z-0818-2011
  • Event Initiated Date
    2010-10-02
  • Event Date Posted
    2010-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94878
  • 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 scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy.
  • Action
    Depuy Spine issued an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" via e-mail on October 2, 2010 to customers. The notification describes the product, problem and action to be taken by customers. The customers were instructed to please distribute this information to appropriate personnel at their facility and return any caddies that they may have to their local distributor for DePuy Spine products. Depuy will return devices to customer promptly (within two business days), after reworking the devices by removing the scale altogether. Once the product is fully corrected, Depuy will provide the customers with a new and updated unit with the corrected scale markings. If you should have any questions or concerns regarding this action, please contact DePuy Spine Customers Service at 800-227-6633.

Device

Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set
  • Model / Serial
    Not lot coded
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AR, AZ, CA, FL, HI, IA, IL, KY, LA, MA, MI, MN, MO, NC, NY OH, PA, TN, TX, VA, and WA.
  • Product Description
    Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile || Product Code: 2883-90-420 || The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws.
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Manufacturer Address
    DePuy Spine, Inc., 325 Paramount Drive, Raynham MA 02767
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA