Events

Recall of Device Recall Logic Fit Tibial Tamp Head

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
    77001
  • Event Risk Class
    Class 2
  • Event Number
    Z-2662-2017
  • Event Initiated Date
    2017-05-25
  • Event Date Posted
    2017-06-19
  • 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=154803
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.E., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
  • Action
    Consignees were sent a Field Advisory Notice dated 5/22/2017 by mail informing them updated surgical techniques are available on Exactech's website (www.exac.com). The notice requested consignees: Extend the information to accounts in possession of the product Complete & return the attached Field Advisory Notice Response Form to Exactech

Device

Device Recall Logic Fit Tibial Tamp Head
  • Model / Serial
    Catalog #: 213-75-01 Lot #'s: 37166-002, 44944-004, 44944-005, 44944-006, 48073-010, 48073-011, 48073-012, 49036-017, 51180-004, 51180-005, 51180-006, 51180-008, 51754-031, 51754-032, 51754-033, 51754-034, 59743-001, 61872-001,and  61872-002.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, France, Germany, India, Italy, Japan, Korea, Luxembourg, Singapore, Spain, Switzerland, The Netherlands and United Kingdom
  • Product Description
    Logic Fit Tibial Tamp Head
  • 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