Events

Recall of Device Recall Concorde Lift

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Orthopaedics, 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
    79072
  • Event Risk Class
    Class 2
  • Event Number
    Z-0849-2018
  • Event Initiated Date
    2017-07-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161277
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Potential for intra-operative breakage of driver tips.
  • Action
    On August 1, 2017, an Urgent Product Recall notice titled "CONCORDE LIFT DRIVER Driver Shaft and Torque Handle" was mailed to customers that received the affected instruments. The letter described the issue, potential hazard, and actions to be taken. The notice instructs customers to cease further distribution or use and to contact a DePuy Synthes Spine sales consultant to return the products subject to recall. Customers are to review, complete, sign, and return the business reply form provided to the firm within 5 business days of receipt of the notification. A copy of the notice should be forwarded to all staff that need to be informed, as well as, any facility that the affected device was further distributed to. Customers should direct any questions regarding this recall to their DePuy Synthes Spine Sales Consultant or the Clarke Madigan, DePuy Synthes Spine Recall Coordinator, at 508-828-609 or DPYUS-SpineFieldActions@its.jnj.com.

Device

Device Recall Concorde Lift
  • Model / Serial
    Product code: 287804102 Lot number: 122315-B R, 122315-A R, 041117A
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Concorde Lift Torque Limiting Handle. || Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Manufacturer Address
    DePuy Orthopaedics, Inc., 325 Paramount Dr, Raynham MA 02767-5199
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA