Events

Recall of Device Recall The HemiCAP Contoured Articular Prosthetic

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arthrosurface, 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
    69723
  • Event Risk Class
    Class 2
  • Event Number
    Z-1112-2015
  • Event Initiated Date
    2014-11-24
  • Event Date Posted
    2015-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131836
  • 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, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
  • Reason
    Fully threaded taper post fixation components not cleared for marketing in the us with current indications.
  • Action
    Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email RA@arthrosurface.com. For questions regarding this recall call 508-528-4604.

Device

Device Recall The HemiCAP Contoured Articular Prosthetic
  • Model / Serial
    Catalog Number: 8135-0032, Part Number: 3135-0032
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
  • Product Description
    Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
  • Manufacturer
    Arthrosurface, Inc.

Manufacturer

Arthrosurface, Inc.
  • Manufacturer Address
    Arthrosurface, Inc., 28 Forge Pkwy, Franklin MA 02038
  • Manufacturer Parent Company (2017)
    ArthroSurface
  • Source
    USFDA