Events

Recall of PERMAHAND Silk Sutures

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, 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
    69787
  • Event Risk Class
    Class 2
  • Event Number
    Z-0492-2015
  • Event Initiated Date
    2014-10-17
  • Event Date Posted
    2015-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131539
  • 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
    Suture, nonabsorbable, silk - Product Code GAP
  • Reason
    Ethicon is unable to ensure that perma-hand silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.
  • Action
    Ethicon sent an Urgent Medical Device Recall Letter/Business Reply Form dated 10/17/2014 via UPS next day mail.

Device

PERMAHAND Silk Sutures
  • Model / Serial
    PERMA-HAND" Silk Suture [Siliconized black braided] Product Code - 10Q06  Lots and Expiration Dates-  GPP528 JUL 2018  GPP908 JUL 2018  HAB605 JAN 2019  HAE019 JAN 2019  HAE964 JAN 2019  HAP987 JAN 2019  HBB681 JAN 2019  HBB952 JAN 2019  HBE186 JAN 2019  HCB084 JAN 2019  HCB972 JAN 2019  HCE266 JAN 2019  HCE980 JAN 2019   PERMA-HAND" Silk Suture [Siliconized black braided]  Product Code - 10Q07  Lots and Expiration Dates-  GPB984 JUL 2018  GPE919 JUL 2018  HAP822 JAN 2019  HBP781 JAN 2019  HCP953 JAN 2019  HCR677 JAN 2019
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA