Events

Recall of 30 Black Mono Nylon Suture

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
    49494
  • Event Risk Class
    Class 3
  • Event Number
    Z-0034-2009
  • Event Initiated Date
    2008-09-09
  • Event Date Posted
    2008-10-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73620
  • 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 - Product Code GAR
  • Reason
    Mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture.
  • Action
    The recalling firm issued a Recall letter dated 9/9/08 to its customers. The letter informed the customers of the problem, the need to conduct a sub-recall, and return the product. Contact Surgical Specialties Corp. at 1-610-404-1000 for assistance.

Device

30 Black Mono Nylon Suture
  • Model / Serial
    Lot number M335870
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA--AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MD, MI, MS, NC, NJ, NY, OH, TN, TX, VA, and WA. OUS: Australia, Canada, and Fiji Islands.
  • Product Description
    3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
  • Manufacturer
    Surgical Specialties Corp

Manufacturer

Surgical Specialties Corp