Events

Recall of Device Recall SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Symmetry Surgical, 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
    71300
  • Event Risk Class
    Class 2
  • Event Number
    Z-2316-2015
  • Event Initiated Date
    2015-06-16
  • Event Date Posted
    2015-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137258
  • 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
    Clamp - Product Code HXD
  • Reason
    Lack of sterility assurance.
  • Action
    The firm initiated their recall by via US certified mail, with return receipt requested, beginning on 06/18/2015. The Urgent Medical Device Recall letter, dated June 16, 2015, identified the affected product, as well as the reason for the recall. The letter discussed the potential harm associated with the issue, and requested that the consignees examine their inventory and discontinue use immediately. Customers should promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impacted lots. Symmetry Surgical Customer Service should be contacted with questions or any other needs.

Device

Device Recall SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP
  • Model / Serial
    149053, 149129, 149143, 149604, 149605, 149606, 149682, 149692, 149837, 149853, 154454, 154455, 154456, 154457, 185696, 228161, 229609, 230233, 259154, 259156, 259160, 268906, 268910, and 271548.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of CA, VA, TX, FL, OH, NY, MS, KY, UT, GA, PA, MO, IN, NV, AL, MI, MA, and LA; and, the countries of Germany and Mexico.
  • Product Description
    SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. || Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.
  • Manufacturer
    Symmetry Surgical, Inc.

Manufacturer

Symmetry Surgical, Inc.