Events

Recall of Device Recall Stylus Brand Slit Knife

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
    26317
  • Event Risk Class
    Class 2
  • Event Number
    Z-0918-03
  • Event Initiated Date
    2003-05-07
  • Event Date Posted
    2003-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27500
  • 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 handle was used in the manufacture of product 52-2761.
  • Action
    On 5/7/03 the cusotmers were notified of the recall via fax.

Device

Device Recall Stylus Brand Slit Knife
  • Model / Serial
    Model number: 52-2761  Lot/Serial # Exp. Date M262530 2/2008 M262540 3/2008 M262550 3/2008
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide. Distribution was to two accounts in the USA and four (4) foreign accounts.
  • Product Description
    2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties Corporation***Reading, PA 19606***''
  • 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