Events

Recall of Device Recall Sharpoint Hydrodissection Cannula

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
    25254
  • Event Risk Class
    Class 3
  • Event Number
    Z-0544-03
  • Event Initiated Date
    2002-11-05
  • Event Date Posted
    2003-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25883
  • 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
    Cannula, Surgical, General & Plastic Surgery - Product Code GEA
  • Reason
    The wrong product in the box.
  • Action
    The domestic account was contacted via fax on 11/8/02 and 12/10/02. The foreign accounts were contacted via email on 11/5-12/02.

Device

Device Recall Sharpoint Hydrodissection Cannula
  • Model / Serial
    Model Number of Device: 3425 Catalog Number: 3425 Lot number: MK10190 exp 11/2006
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was sent to wholesalers in CA, Spain and Australia
  • Product Description
    25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End
  • Manufacturer
    Surgical Specialties Corp

Manufacturer

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