Events

Recall of Device Recall Alteon Neck Preserving Stem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Exactech, 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
    75989
  • Event Risk Class
    Class 2
  • Event Number
    Z-1032-2017
  • Event Initiated Date
    2016-11-07
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151895
  • 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/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    Products were labeled with incorrect global trade item numbers. the gtin on the label identifies the devices as another.
  • Action
    In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at kaya@exac.com or 1-800-392-2832.

Device

Device Recall Alteon Neck Preserving Stem
  • Model / Serial
    Serial No. 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, 4558261-4458262; Catalog No. 162-00-06; UDI: 10885862262776
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
  • Product Description
    Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
    Exactech Inc
  • Source
    USFDA