Events

Recall of In Situ Bender Cutter Kit Wide 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
    51702
  • Event Risk Class
    Class 2
  • Event Number
    Z-1640-2009
  • Event Initiated Date
    2009-04-03
  • Event Date Posted
    2009-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81434
  • 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
    Bone Fixation Plate - Product Code HRS
  • Reason
    Sterility may be compromised due to a ineffective package design.
  • Action
    All affected Synthes DMF Sales Consultants were notified of the Medical Device Recall by an Urgent: Medical Device Recall letter notification which was sent via USPS certified mail on 4/6/09. The letter stated the problem and risk. The firm recommended that patients who have had a surgical procedure in which these products were utilized be monitored for signs/symptoms of infection for a period of six months following surgery. If customers have any of the identified devices, they are to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the form; and return the letter with the recalled product to the address provided. Customers that do not have the identified product, are to complete the attached form and return the document to the address provided acknowledging their receipt of the recall information. Questions should be directed to their Synthes CMF Sales Consultant.

Device

In Situ Bender Cutter Kit Wide Sterile
  • Model / Serial
    Lot numbers TM00119 exp 6/30/05, TM00122 exp 7/31/04, TM00124 exp 7/31/04, TM00128 exp 9/30/05, TM00150 exp 10/31/06, TM00155 exp 3/9/07, TM00160 exp 12/29/08, TM00172 exp 3/30/09, TM00197 exp 7/31/09, TM00220 exp 9/7/09, TM00221 exp 9/7/09, TM00260 exp 3/10/10, TM00271 exp 4/28/10, TM00295 exp 10/10/10, TM00315 exp 2/28/11, TM00322 exp 4/13/11, 4859489 exp 7/30/05, 4859490 exp 6/30/05, 4859492 exp 7/31/05, and TM00341 exp 3/12/12.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the country of Canada.
  • Product Description
    In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S || Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children.
  • 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