Events

Recall of Device Recall Howmedica Osteonics Corp.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

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
    62365
  • Event Risk Class
    Class 2
  • Event Number
    Z-2084-2012
  • Event Initiated Date
    2011-12-22
  • Event Date Posted
    2012-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110358
  • 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
    Stryker orthopaedics received a report indicating that a tibial keel punch could not be inserted into the slot of the tibial punch tower. the slot that guides the stem of the keel punch into the channel of the tower was later determined to be undersized.
  • Action
    Stryker Orthopaedics sent an Urgent Product Recall/Recall Acknowledgement letter dated January 10, 2012, to all affected customers. The letter identified the product(s) the problem and the action needed to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of the affected product. Customers were asked to fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069. For questions customers should call 201-972-2100. For questions regarding this recall call 201-831-5970.

Device

Device Recall Howmedica Osteonics Corp.
  • Model / Serial
    Catalog Number 8000-1089. Lot Number(s): RD6E087, RD6E187; RD6E083; RD6E082; RD6C178; RD5W268; RD5W267; RD5V260; RD5W320; RD5V240; RD5V239; RD5V238; RD5N407; RD5S104; RD5S103; RD5T177; RD5T179; RD5S259; RD5T178; RD5N406; RD5S300; RD5T298; RD5W381; RD6E086; RD6E089; RD6E090; RD6E091; RD6E158; RD6E159; RD6E160; RD6E186.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. || During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and Tibial Templates (3750-0003/-0005/-0007/-0009/-0013) to prepare the tibia for baseplate implantation. Per the surgical protocol for Duracon and Scorpio Total Knee Systems with Xcelerate Instrumentation (LSPK31 03/03), tibial templates are used to determine the appropriate coverage of the tibial plateau. Once a template size is selected, the device is secured to the plateau with fixation pins, and the tibial punch tower is assembled by placing the tower onto the two small locating pins on the tibial template. A keel punch is then selected, assembled into the channel of the tower, and impacted with a mallet. Depending on the intended implant size, several keel punches of increasing size may be utilized to incrementally enlarge the cavity. Each keel punch is advanced until it fully seats on the tibial template. Tibial preparation is considered complete when the final keel punch fully seats on the tibial template.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA