Events

Recall of Device Recall Sharpoint 40 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
    58449
  • Event Risk Class
    Class 3
  • Event Number
    Z-2138-2011
  • Event Initiated Date
    2011-03-30
  • Event Date Posted
    2011-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99373
  • 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, Cardiovascular - Product Code DTH
  • Reason
    Mislabeled - a number of units of the product labeled as 4-0 black mono nylon suture product contain a 4-0 black braided silk suture.
  • Action
    Surgical Specialites sent an Urgent Product Recall Notification letter on March 30, 2011, along with an attached Customer Acknowledgment Form to the affected consignees. It was reported that upon opening a box labeled as 4.0 Black Mono Nylon, it was observed that the package acutally contained 4-0 Black Braided Silk suture. Customers were to review their current inventory, segregate the affected lot number and / or contact their customer accounts that have purchased this specific item / lot code requesting a return of the product to customers' facility. To ensure customers have received this notification and to arrange for credit and the return of identified product, the Customer Acknowledgment Form should be completed and returned via fax to our Quality Assurance department at (610) 404-8488.

Device

Device Recall Sharpoint 40 Nylon Suture
  • Model / Serial
    Product Code - AC-0584D, lot number M446840
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Class 3 Recall - Worldwide Distribution-- USA and Australia.
  • Product Description
    SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. || Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures.
  • Manufacturer
    Surgical Specialties Corp

Manufacturer

Surgical Specialties Corp