Events

Safety Alert for Cross-Link Clamp for Rods Ø 6.0 mm, preassembled, Titanium Alloy (TAN), dark blue

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by DePuy Synthes.

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
    2015-03-19
  • Event Date Posted
    2015-03-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150319.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: depuy synthes cross-link clamp for rods ø 6.0 mm, preassembled, titanium alloy (tan), dark blue medical device manufacturer, depuy synthes, has issued a medical device safety alert concerning cross-link clamp for rods ø 6.0 mm, preassembled, titanium alloy (tan), dark blue [part number: 498.813(s). lot numbers: 2780518, 2781527, 2780516, 2780511, 2780509, 2780507]. due to an error in production, the affected lots cannot be securely attached to the 6 mm longitudinal rods. this may result in surgical delay as the affected device cannot be tightened appropriately during surgery and an alternative device is required. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 march 2015.

Device

Cross-Link Clamp for Rods Ø 6.0 mm, preassembled, Titanium Alloy (TAN), dark blue
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: DePuy Synthes Cross-Link Clamp for Rods Ø 6.0 mm, preassembled, Titanium Alloy (TAN), dark blue
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes