Events

Recall of Device Recall Synthes 4.5MM TI VALCP CRVD Condylar Plate/6H/159MM/RTSTER

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes USA HQ, 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
    66723
  • Event Risk Class
    Class 2
  • Event Number
    Z-0401-2014
  • Event Initiated Date
    2013-05-29
  • Event Date Posted
    2013-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123143
  • 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
    condylar plate fixation Implant - Product Code JDP
  • Reason
    A plate was inadvertently released to a sales consultant that was restricted for sale.
  • Action
    Synthes sent a letter dated November 7, 2013, to the implanting surgeon to follow up on a complaint received. The firm requested any additional information the surgeon might have about the use of the plate as well as a status on the patient following use. For questions the surgeon was instructed to call 800-620-7025. For questions regarding this recall call 610-719-5000.

Device

Device Recall Synthes 4.5MM TI VALCP CRVD Condylar Plate/6H/159MM/RTSTER
  • Model / Serial
    part 04.124.406S, lot 3771678.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution in Colorado.
  • Product Description
    Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER || Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

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