Events

Recall of Device Recall Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set

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
    68738
  • Event Risk Class
    Class 2
  • Event Number
    Z-2265-2014
  • Event Initiated Date
    2014-06-30
  • Event Date Posted
    2014-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128584
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. initial investigative testing indicated the components within the set may be cytotoxic.
  • Action
    An Urgent Field Safety Notification, dated July 21, 2014, was sent to surgeons explaining the product, problem, and action to be taken with regard to routine post-operative follow-up on patients exposed to the affected product. Questions or concerns should be directed to Leonie Rynn at 610-719-5408 or lrynn1@its.jnj.com.

Device

Device Recall Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
  • Model / Serial
    Part Number: 145.17E Lot Number: EV01609, individual part numbers contained within 145.17E:  304.49 309.501 310.221 310.804 311.43 312.151 312.153 313.969 314.463 314.464 314.465 319.291 319.292 319.702 319.97 398.408 398.409 402.608-402.640 402.714-402.740 419.89 419.972 292.622, and  292.623.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of WI and MI.
  • Product Description
    Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
  • 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