Events

Recall of Device Recall Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Surgical Specialties Corp.

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
    25816
  • Event Risk Class
    Class 2
  • Event Number
    Z-0705-03
  • Event Initiated Date
    2003-01-07
  • Event Date Posted
    2003-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26523
  • 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
    Size mislabeled on product handle.
  • Action
    On 1/7/03, one account was contacted via telephone. On 1/10/03, a recall letter was faxed to that account. On 3/11/03, this wholesale account was asked to contact a hospital sub account that received a direct shipment. The other account was the complainant and telephone communications were occurring.

Device

Device Recall Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife
  • Model / Serial
    Model # 75-2525, Lot #M118200
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was shipped to 2 wholesale accounts in PA and LA.
  • Product Description
    Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.
  • Manufacturer
    Surgical Specialties Corp

Manufacturer

Surgical Specialties Corp
  • Manufacturer Address
    Surgical Specialties Corp, 100 Dennis Drive, Reading PA 19606-3776
  • Source
    USFDA