Events

Recall of Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.

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
    31985
  • Event Risk Class
    Class 2
  • Event Number
    Z-0241-06
  • Event Initiated Date
    2004-11-22
  • Event Date Posted
    2005-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38869
  • 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
    Nail, Fixation, Bone, Metallic - Product Code NDH
  • Reason
    The gamma nail may have been manufactured with an incorrect lag screw hole angulation. catalog number 3225-0360s, lot code k949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. catalog number 3220-0320s, lot code k949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.
  • Action
    Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.

Device

Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
  • Model / Serial
    Catalog 3220-0320S Lot K949408  3225-0360S, lot code K949396
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account.
  • Product Description
    Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA