Events

Recall of Device Recall Cervical Spine Locking Plate (CSLP) System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products LLC.

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
    73549
  • Event Risk Class
    Class 2
  • Event Number
    Z-1524-2016
  • Event Initiated Date
    2016-01-06
  • Event Date Posted
    2016-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144448
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Reason
    Depuy synthes is initiating a voluntary medical device recall of lot # 9666776 and 9671879 of cancellous and cortex 4.0 mm screws, which are a part of the cervical spine locking plate (cslp) system due to discovery of a single lot of 450.136 screws (4mm cancellous self tapping screw, length 16mm, lot 9666776) being swapped with a single lot of 450.016 (4mm cortex standard screw, length 16 mm, lot 9671879).
  • Action
    DePuy Synthesis sent an Urgent Notice Medical Device Recall letter dated January 6, 2016 to customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers to complete and return the attached Verification Section (page 3 of the letter). For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Device

Device Recall Cervical Spine Locking Plate (CSLP) System
  • Model / Serial
    Lot # 9666776 (catalog ID 450.136) and 9671879 (catalog ID 450.016)
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of NC, CA, NY, TX, NJ, CO and the countries of: Ontario and Canada.
  • Product Description
    Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA