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-0947-04
  • 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=32923
  • 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 52-2661 M309600 5/2008 52-2662 M309610 8/2008 52-2661 M309620 8/2008 52-2661 M309630 8/2008 52-2661 M264510 3/2008 52-2761 M436360 12/2008 52-2761 M309720 9/2008 52-2761 M309730 9/2008 52-2761 M365020 10/2008 52-2761 M365030 11/2008 52-2861 M309770 5/2008 52-2861 M309780 7/2008 52-2861 M430490 12/2008 52-2861 M437160 1/2009 52-2861 M439540 1/2009 52-2861 M309790 8/2008 52-2861 M309810 9/2008 52-2961 M376790 8/2008 52-2961 M309860 6/2008 52-2961 M309870 7/2008 52-2961 M416990 10/2008 52-3261 M440600 2/2009 52-3261 M262580 3/2008 52-3261 M309940 7/2008 52-3261 M309960 8/2008 52-3261 M309970 8/2008 52-3561 M311070 4/2008 52-2662 M445610 2/2009 52-3262 M280120 3/2008
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide and internationally
  • Product Description
    Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm || 52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm || 52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm || 52-2961, Slit Knife, bevel up, angled, full handled, 3.0mm || 52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm || 52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm || 52-2662, Slit Knife, bevel up, angled, blade and tip, 3.2mm || 52-3262, Slit Knife, bevel up, angled, blade and tip, 3.2mm
  • 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