Events

Recall of Synthes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes, 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
    68190
  • Event Risk Class
    Class 2
  • Event Number
    Z-1669-2014
  • Event Initiated Date
    2014-04-29
  • Event Date Posted
    2014-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127119
  • 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
    Bit, surgical - Product Code GFG
  • Reason
    Certain lots of the prodisc-c 2.0mm milling bits have an increased potential to break during use.
  • Action
    DePuy Synthes sent a Recall letter, dated April 29, 2014, to affected customers. The letter identified the affected customers, problem and actions to be taken. The letter instructed customers to discontinue use and distribution of the device and to return affected devices to Synthes. For questions call 610-719-5450.

Device

Synthes
  • Model / Serial
    part number: 03.820.161s, with lot numbers: 5742507,5755970,5755971,5755972, 5755973,5755974,5828298,6336115, 6338099,6338100,6340029,6340030, 6344199,6344200,6363601,6385892, 6407046,6431260,6431261,6460402, 6503360,6526127,6571070,6571073, 6571074,6601985,6636946,6636947, 6636948,6653819,6653820,6670383, 6691341,6691342,6718933,6718934, 6718935,6740611,6794651,6794652, 6794653,6794654,6794655  part number: 03.820.1638 with lot numbers: 5742506,5755978,5755979,5755980, 5755981,5755982,5828299,5828300, 6320586,6336108,6336110,6336111, 6340033,6344201,6344202,6363602, 6385893,6431262,6431263,6460403, 6503361,6571075,6601986,6601987, 6636949,6636950,6636951,6653810, 6653818,6670382,6691343,6691344, 6718938,6740615,6740616,6745821, 6770474,6770475,6770476,6770477, 6770478,6794657,6794658  part number: 03.820.167S with lot numbers:  5755983,5755984,5755987,5755988, 5755989,5755985,5755986,5755990, 5828302,6338101,6338102,6338103, 6338104,6338106,6338107,6338108, 6338109,6344205,6471089,6670381, 6718939,6718940,6718941,6843907, 6843906,6856252,6856253,6867662, 6867661,6901712,6901713,6919726, 6919727,6919728,6901710,6901711, 6921717,6921718,6940357,6960192, 6960193,6983033,7006496,7055427  part number: 03.820.169S with lot numbers: 6066520,6113671,6113633,6159883, 6180175,6338068,6338098,6344206, 6363603,6407047,6431264,6460404, 6526128,6571078,6670384,6745820, 6770479,6770480
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Manufacturer Address
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA