Events

Recall of MIKA Speed Block

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encore Medical, Lp.

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
    37878
  • Event Risk Class
    Class 3
  • Event Number
    Z-1139-2007
  • Event Initiated Date
    2006-08-15
  • Event Date Posted
    2007-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52040
  • 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 implant positioning device - Product Code LKH
  • Reason
    Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
  • Action
    Firm sent notification letter to consignees on 08/25/2006, along with replacement speedblocks. Consignees asked to trade out old speedblocks with the replacements.

Device

MIKA Speed Block
  • Model / Serial
    M.I.K.A. Surgical Kits: MIKA-05-001, MIKA-05-002, MIKA-05-003, MIKA-05-004, MIKA-05-005, MIKA-05-006, MIKA-05-007, MIKA-05-008, MIKA-05-009, MIKA-05-010, MIKA-05-016, MIKA-05-018, MIKA-05-019, MIKA-05-020, MIKA-05-021, MIKA-05-022, MIKA-05-023, MIKA-05-024, MIKA-05-025, MIKA-05-026, MIKA-05-027, MIKA-05-028, MIKA-05-029, and MIKA-05-030.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product distributed to direct accounts in USA and one consignee in Japan.
  • Product Description
    Femoral Speed Block Size 12, Part/Catalog #800-01-370; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Austin, TX 78758.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA