Events

Recall of Device Recall PRODISC

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
    76487
  • Event Risk Class
    Class 2
  • Event Number
    Z-1383-2017
  • Event Initiated Date
    2017-01-31
  • Event Date Posted
    2017-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153344
  • 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
    These items are incorrectly etched and labeled. the item etched and labeled as 10mm strut 03.820.350 lot 5919005 is a 12 mm strut. the item etched and labeled as 12 mm strut 03.820.352 lot 5919006 is a 10 mm strut.
  • Action
    DePuy Synthes mailed an Urgent Notice to customers affected by the issue on 02/13/2017. The reason for the recall was explained, risks associated with the issue were identified, and actions to be taken were addressed. Customers were asked to complete the enclosed Verification form and mail it back to obtain a Return Authorization Number for the product's return. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant. For questions regarding this recall call 800-479-6329.

Device

Device Recall PRODISC
  • Model / Serial
    Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US distribution to TX and LA
  • Product Description
    PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. || Part numbers 03.820.350 and 03.820.352. || Used to hold the disc segment open and facilitate discectomy
  • 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