Events

Recall of SHARPOINT IQ Geometry Slit 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. dba Angiotech PR 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
    62945
  • Event Risk Class
    Class 2
  • Event Number
    Z-0201-2013
  • Event Initiated Date
    2012-08-15
  • Event Date Posted
    2012-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112324
  • 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
    Blade, scalpel - Product Code GES
  • Reason
    Potential for bent tips.
  • Action
    Angiotech sent an Urgent Product Recall Notification letter dated August 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the current inventory, segregate the affected lot numbers, and to return the identified product. Customers were asked to complete the attached Customer Acknowledgement Form and fax to the Quality Assurance department at 787-658-1073. If product was further distributed customers should notify their customers to whom they sold the affected product. Customers with questions should call 787-658-1800 option 2 ext. 1775 or 787-658-1800 option 2 ext 1807. For questions regarding this recall call 787-658-1800.

Device

SHARPOINT IQ Geometry Slit Knives
  • Model / Serial
    MAFD350, M381400, M407870, M439070, M439090, M466140, M495140, M495190, M510800, M554700, M554740, M585650, M656720, M656730, MABL380, MABQ000, MADM740
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand
  • Product Description
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" || Ophthalmic surgery
  • Manufacturer
    Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.

Manufacturer

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
  • Manufacturer Address
    Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc., Rd 459 Km 0.6, Montana Industrial Park, Aguadilla PR 00605
  • Manufacturer Parent Company (2017)
    Angiotech Pharmaceuticals, Inc.
  • Source
    USFDA