Events

Safety Alert for Epoca Stem Extractors and Connection Screws

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Synthes 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
  • Date
    2018-03-28
  • Event Date Posted
    2018-03-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180328.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: synthes gmbh epoca stem extractors and connection screws medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its epoca stem extractors and connection screws. the affected devices are identified as follow: - stem extractor f/guide bar part number: 03.401.072; lot numbers: 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949 screw m6x18 part number: 03.401.077; lot number: 10-4566 the manufacturer is initiating a voluntary field safety notification (fsn) for the part and lot numbers of the epoca stem extractors and connection screws. there is a potential for the connection screw (p/n 03.401.077) of the stem extractor (p/n 03.401.072) to break. this breakage could occur during the step 3 “head/eccenter removal and humeral stem extraction” shown and described on page 10 of the surgical technique “epoca revision set” [dsem/trm/0714/0131(1)]. “to remove the stem, mount and fully tighten the stem extractor using the hexagonal wrench. mount the ram/guide bar and apply gentle blows.” according to the manufacturer, if the stem extractor breaks, the potential impact to the patient includes surgical delay, bone damage, and/or adverse tissue reaction. the affected users are asked to review the instructions listed in the fsn. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 march 2018.

Device

Epoca Stem Extractors and Connection Screws
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes GmbH Epoca Stem Extractors and Connection Screws
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH