Events

Recall of Microseal Augmented (20 degree) Liner

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Signal Medical 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
    69418
  • Event Risk Class
    Class 2
  • Event Number
    Z-0109-2015
  • Event Date Posted
    2014-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130490
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Reason
    Incorrect dimension on four liners was detected.
  • Action
    Signal Medical Corporation verbally notified the only consignee via telephone. Please call Signal Medical Corp. at 1-800-246-6324 with any questions.

Device

Microseal Augmented (20 degree) Liner
  • Model / Serial
    Catalog #: WB-1-1122, Size: 36x52x20, Serial # B13085  Catalog #. WB-1-1110 Size: 36x50x20, Serial # B13099  Catalog # WB-1-1110, Size: 36x50x20, Serial #: B13105  Catalog # WB-1-1110, Size: 36x50x20, Serial # B13106
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution in MO only.
  • Product Description
    Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. || Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement.
  • Manufacturer
    Signal Medical Corporation

Manufacturer

Signal Medical Corporation
  • Manufacturer Address
    Signal Medical Corporation, 400 Pyramid Dr, Marysville MI 48040-2463
  • Manufacturer Parent Company (2017)
    Signal Medical Corporation
  • Source
    USFDA