Events

Recall of Device Recall Implant Holder for SynFixLR

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
    56343
  • Event Risk Class
    Class 2
  • Event Number
    Z-2583-2010
  • Event Initiated Date
    2010-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93275
  • 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
    Spinal vertebral body replacement device - Product Code MQP
  • Reason
    A potential for the implant holder tip to break off and lodge in the synfix-lr implant, which pose a potential risk to the patient.
  • Action
    Synthes Spine Hospital sent an ' URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated August 20, 2010 to all customers. The letter described the labeling issue and actions to be taken by the customers. The customers were instructed to review the supplementary labeling provided; contact their Synthes Spine Sales Consultant to arrange for provision of the Holding Forceps (p/n 388.401) prior to each SynFix-LR procedure; and complete and return the enclosed Verification Section form to Synthes via fax at 610-251-9005 or email: FieldAction@Synthes.com. If you have any questions, please call 1-800-620-7025 x 3500 or contact your Synthes Spine Sales Consultant.

Device

Device Recall Implant Holder for SynFixLR
  • Model / Serial
    Catolog Number: 03.802.039 - all lot numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: USA and the countries of Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore.
  • Product Description
    SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) || The implant holder is used to place the implant into the vertebral disc space.
  • 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