Events

Recall of Device Recall Circumcision Clamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Deroyal Industries, Inc. Lafollette.

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
    59770
  • Event Risk Class
    Class 2
  • Event Number
    Z-3253-2011
  • Event Initiated Date
    2011-05-05
  • Event Date Posted
    2011-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103657
  • 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, circumcision - Product Code HFX
  • Reason
    The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by surgical design.
  • Action
    DeRoyal Industries, Inc. sent a recall notification letter dated 05/05/2011. A second notice was sent on 07/26/2011 to affected customers who did not respond to the initial notice. Questions regarding this recall may contact the Corporate Attorney at (865) 362-1037.

Device

Device Recall Circumcision Clamp
  • Model / Serial
    Lot Number 21989639
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.
  • Product Description
    DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Circumcision Clamp
  • Manufacturer
    Deroyal Industries, Inc. Lafollette

Manufacturer

Deroyal Industries, Inc. Lafollette
  • Manufacturer Address
    Deroyal Industries, Inc. Lafollette, 1501 East Central Ave, La Follette TN 37766-2892
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA