Events

Recall of Device Recall Stylus Brand Angled Knives

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Surgical Specialties Puerto Rico, 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
    28948
  • Event Risk Class
    Class 2
  • Event Number
    Z-0946-04
  • Event Initiated Date
    2004-03-03
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32917
  • 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
    Knife, Ophthalmic - Product Code HNN
  • Reason
    Incorrect placement of the blade in the foam of product results in blade poking through packaging. compromised sterility and injury to healthcare worker.
  • Action
    Customers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606.

Device

Device Recall Stylus Brand Angled Knives
  • Model / Serial
    Model No. Lot # Exp. date 56-5361 M262510 5/2008 56-5361 M309090 6/2008 56-5361 M309150 11/2008 56-5361 M439510 1/2009 56-5161 M317030 6/2008
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide and internationally
  • Product Description
    Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip Knife, bevel up, angled, full handled, 5.2mm
  • Manufacturer
    Surgical Specialties Puerto Rico, Inc.

Manufacturer

Surgical Specialties Puerto Rico, Inc.
  • Manufacturer Address
    Surgical Specialties Puerto Rico, Inc., Road 115 Km.12.9, Rincon PR 00677
  • Source
    USFDA