Events

Recall of Codman(R) Collins Radioparent Sternal Blade Nylon

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Symmetry Medical/SSI.

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
    64962
  • Event Risk Class
    Class 2
  • Event Number
    Z-1267-2013
  • Event Initiated Date
    2013-04-10
  • Event Date Posted
    2013-05-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117536
  • 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
    Instruments, surgical, cardiovascular - Product Code DWS
  • Reason
    There is a possibility that the collins radioparent sternal blades nylon may break during use.
  • Action
    Symmetry Surgical sent an Urgent Medical Device Recall letter dated April 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. If so, customers were instructed to discontinue use of the product immediately and promplty call 800-251-3000 for a return material authorization (RMA) number and to identify if they would like credit or an alternative product. Customers were asked to fill out the attached Recall Response Form and fax the completed form to 615-964-5567. Customers with questions were instructed to call 615-964-5515. For questions regarding this recall call 615-964-5515.

Device

Codman(R) Collins Radioparent Sternal Blade Nylon
  • Model / Serial
    244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK
  • Product Description
    Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 || sternum retractor
  • Manufacturer
    Symmetry Medical/SSI

Manufacturer

Symmetry Medical/SSI
  • Manufacturer Address
    Symmetry Medical/SSI, 3034 Owen Dr, Antioch TN 37013-2413
  • Manufacturer Parent Company (2017)
    Tecomet Inc.
  • Source
    USFDA