Events

Safety Alert for Instrument Implant Hip System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Stryker Leibinger Gmbh & Co. Kg || Stryker Gmbh.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1705-181
  • Event Number
    2008DM-0002104
  • Date
    2017-05-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it has detected that the screws were manufactured with the wrong material; titanium grade 4 (t014) was used instead of titanium grade 5 (t005), however, both materials are used in the manufacture of deosteosynthesis material and have a good biocompatibility behavior, however it could potentially lead to the presentation of adverse events on the patients or reinterventions.

Device

Instrument Implant Hip System
  • Model / Serial
  • Product Description
    The material for osteosynthesis of small fragments of STRYKER is a set of plates, screws, washers and their instrumentation associated with other procedures of osteosynthesis of small bones such as: treatment and surgery of small bones, including those of the hand and wrist; internal fixation of the bones of the hand and wrist; internal fixation, reconstruction oartrodesis of small bones, including the forefoot, midfoot and hindfoot; for the treatment of: delescafoid fractures; fractures of the other carpal bones; pseudoarthrosis of the scaphoid; intercarpal arthrodesis; arthrodesis of the distal and proximal interphalangeal joints; fractures of the ulnar and radial epiphyses; osteotomies of transposition of the forefoot; for use in the internal fixation of fractures and distal radius reconstructions.
  • Manufacturer
    Stryker Leibinger Gmbh & Co. Kg || Stryker Gmbh

Manufacturer

Stryker Leibinger Gmbh & Co. Kg || Stryker Gmbh
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NIDFSINVIMA