Events

Recall of Device Recall Sharpoint

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

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
    74230
  • Event Risk Class
    Class 2
  • Event Number
    Z-2042-2016
  • Event Initiated Date
    2016-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146903
  • 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
    Suture, nonabsorbable, synthetic, polypropylene - Product Code GAW
  • Reason
    Surgical specialties is recalling sharpoint polyproplyene blue monofilament 6"/15cm 9-0 usp because it may contain black nylon 9-0 suture.
  • Action
    A customer notification letter dated 5/20/16 was sent to all customers to inform them that Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture. Customers are instructed to complete the attached customer acknowledgement form and return via fax to Surgical Specialties' Quality Assurance department at (610) 404-4010 or return via email to kknappenberger@surgicalspecialties.com. Customers with any questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083.

Device

Device Recall Sharpoint

Manufacturer

SSC- Surgical Specialties Corporation
  • Manufacturer Address
    SSC- Surgical Specialties Corporation, 9993 Marconi Dr, San Diego CA 92154-7271
  • Source
    USFDA