Events

Recall of Device Recall DePuy Spine

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
    58271
  • Event Risk Class
    Class 2
  • Event Number
    Z-2103-2011
  • Event Initiated Date
    2011-03-22
  • Event Date Posted
    2011-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98846
  • 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
    Spinal channeling instrument, vertebroplasty - Product Code OCJ
  • Reason
    Mislabeled: package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle.
  • Action
    The firm, DePuy Spine, sent an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" letter dated March 22, 2011 to its consignees/customers ( hospital sites and domestic sales distributors). A product reconciliation form was provided to assist in the retrieval of affected product. The letter described the product, problem and actions to be taken. The customers were instructed to return any needles that they may have to their local Distributor for DePuy Spine products and complete and return the Product Reconciliation Form via fax to 508-828-3762; call Customer Service at 877-379-4871 to receive a return goods authorization number and/or mail the form with the return product to DePuy Spine Inc., 50 Scotland Boulevard, Bridgewater, MA 02324, Attn: CONFIDENCE NEEDLE RECALL COORDINATOR, RGA #. If you have any questions or concerns with regard to this notice, please contact the DePuy Spine Regulatory Compliance Department at 508-828-2790.

Device

Device Recall DePuy Spine
  • Model / Serial
    Lot Code: HLPB4F
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: AZ, IA, LA, TX, NE, NJ ,NY, PA, VA, and WA; and countries of: Canada, Australia, Belgium, France,Hungary, Italy, Malaysia, Solvenia, UK, South Africa, Switzerland, and UAE.
  • Product Description
    Confidence¿ Introducer Needle Side Hole 13G x 4-Inch || Product Code: 2839-04-413 || The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw.
  • 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