Events

Recall of 1100 Series Aluminum Retractors

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lone Star Medical Products, 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
    36592
  • Event Risk Class
    Class 2
  • Event Number
    Z-0212-2007
  • Event Initiated Date
    2004-10-06
  • Event Date Posted
    2006-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48962
  • 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
    Retractors - Product Code GAD
  • Reason
    Ni-cr plated 1100 series retractors with a chromium finish were replaced by retractors with a hard-anodized finish after complaints of peeling were received.
  • Action
    For domestic customers, the firm sent product replacement letters to customers (as listed on the firm's invoices), and hospital operating room personnel on October 6, 2004. On November 8, 2004, a faxed letter was sent to the Purchasing/Materials Management Department of all customers. From November 9 through November 12, 2004, a phone call drive was conducted to contact appropriate individuals for each customer. For international customers, the firm notified distributors and obtained end user details from them. End users were then contacted and communicated with regarding the product replacement. In addition, the firm utilized its Summer and Fall 2004 newsletters to communicate the product replacement information. Customers were encouraged to return NiCr coated products for a hard-anodized coated replacement product.

Device

1100 Series Aluminum Retractors
  • Model / Serial
    Lot #6000 (Serial numbers: 1480 thru 1489); Lot #6058 (Serial numbers: 1490 thru 1493 and 1534 thru 1539); & Lot #6155 (Serial numbers: 1540 thru 1559).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.
  • Product Description
    Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104; manufactured by Lone Star Medical Products, Inc.
  • Manufacturer
    Lone Star Medical Products, Inc

Manufacturer

Lone Star Medical Products, Inc
  • Manufacturer Address
    Lone Star Medical Products, Inc, 11211 Cash Rd, Stafford TX 77477
  • Source
    USFDA