Events

Recall of Device Recall Arthrosurface ToeMotion"

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
    72695
  • Event Risk Class
    Class 2
  • Event Number
    Z-0475-2016
  • Event Initiated Date
    2014-06-09
  • Event Date Posted
    2015-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141991
  • 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, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained - Product Code LZJ
  • Reason
    An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. the component did not pass a half-cycle sterilization.
  • Action
    The distributors were verbally notified, and replacement Rev F Hex Drivers sent to the locations of the kits. The kits had been moved in preparation for upcoming surgeries, but the Drivers were replaced prior to any additional surgery taking place. No affected product remains in the field. For further questions, please call (508) 520-3003.

Device

Device Recall Arthrosurface ToeMotion"
  • Model / Serial
    SN 000242 SN 000244 SN 000246 SN 000247
  • Product Classification
    Orthopedic Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : PA, WV and CA.
  • Product Description
    Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 || The component in question is the hex driver (part number 2009-4001).
  • Manufacturer
    Arthrosurface, Inc.

Manufacturer

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