Events

Recall of Device Recall Circumcision Clamp, models 1.1cm and 1.3cm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Surgical Design 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
    58318
  • Event Risk Class
    Class 2
  • Event Number
    Z-2153-2011
  • Event Initiated Date
    2011-01-26
  • Event Date Posted
    2011-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98978
  • 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
    Circumcision Clamp - Product Code HFX
  • Reason
    Medical device used in surgical procedure is defective and may break during use.
  • Action
    Surgical Design, Inc. sent a Customer letter dated February 23, 2011, informing them of the affected product and providing instructions for its specific consignees. The instructions to the User is to please check your inventory to determine whether any Circumcision Clamps bought directly match those on your shelves. Please fill out the form and mail it to Surgical Design at the address on the form. If any clamps from the affected lots remain in your inventory, please ship them back to Surgical Design, noting the number being returned on the Reply form. These are the affected Lots. 100210 (1.3cm) 100211 (1.1cm) and 100060409 (1.3cm) If you have any further questions, please call (703) 541-0196.

Device

Device Recall Circumcision Clamp, models 1.1cm and 1.3cm
  • Model / Serial
    Lots: 100210 (1.3 cm),  100211 (1.1 cm), 100060409 (1.3 cm)
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class 2 Recall -- Nationwide Distribution.
  • Product Description
    Circumcision Clamp, models 1.1 cm and 1.3 cm, || Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
  • Manufacturer
    Surgical Design Inc

Manufacturer

Surgical Design Inc
  • Manufacturer Address
    Surgical Design Inc, 7351 Lockport Pl Ste D, Lorton VA 22079-1571
  • Manufacturer Parent Company (2017)
    Surgical Design Inc.
  • Source
    USFDA