Events

Recall of Device Recall InSitu Bender Cutter Kit Narrow Sterile

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes Spine.

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
    51422
  • Event Risk Class
    Class 2
  • Event Number
    Z-1249-2009
  • Event Initiated Date
    2008-12-18
  • Event Date Posted
    2009-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80252
  • 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
    craniofacial system instrument - Product Code HRS
  • Reason
    The bender is heating prior to activation of the power button, requiring disassembly to stop heating.
  • Action
    All affected Synthes CMF Sales Consultants were notified of the Medical Device Recall by phone on 12/19/08 and by letter sent via return receipt email on 12/22/08. All affected hospitals were notified by letter mailed on 12/22/08 via USPS certified mail.

Device

Device Recall InSitu Bender Cutter Kit Narrow Sterile
  • Model / Serial
    Catalog number 530.522S - Lot number TM00324 exp 4/8/10
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT
  • Product Description
    Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures.
  • Manufacturer
    Synthes Spine

Manufacturer

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