Events

Recall of Device Recall ELEOS LIMB SALVAGE SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Onkos Surgical, 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
    77309
  • Event Risk Class
    Class 2
  • Event Number
    Z-2648-2017
  • Event Initiated Date
    2017-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156330
  • 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, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Reason
    The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm.
  • Action
    On May 23, 2017 Onkos Surgical distributed Medical Device Recall notices to their customers via courier service. Customers were advised to return the affected parts within 2 business days to: Millstone Medical 8836 Polk Lane, Suite 100 Olive Branch, MS 38654 ATTN: Anwar Powell/Recalled Product (662) 892-3612 ext. 1809. Questions regarding this recall can be addressed to: Jan Triani Senior Director of Quality Assurance and Regulatory Affairs jtriani@onkossurgical.com (973) 264-5400, M-F 8:30 am - 5:00 pm.

Device

Device Recall ELEOS LIMB SALVAGE SYSTEM
  • Model / Serial
    LOT 1699599
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AZ, IL & KS
  • Product Description
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
  • Manufacturer
    Onkos Surgical, Inc.

Manufacturer

Onkos Surgical, Inc.
  • Manufacturer Address
    Onkos Surgical, Inc., 77 E Halsey Rd, Parsippany NJ 07054-3714
  • Manufacturer Parent Company (2017)
    Onkos Surgical Inc.
  • Source
    USFDA