Events

Safety Alert for Repliform Tissue Regeneration Matrix

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

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
    2015-05-14
  • Event Date Posted
    2015-05-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150514.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: boston scientific repliform tissue regeneration matrix medical device manufacturer, boston scientific, has issued a medical device safety alert concerning repliform tissue regeneration matrix [material number (upn): m0068202410; lot: ah102318010, ah102317009, ah102318026; expiration date: 31 january 2017]. boston scientific, as the distributor of lifecell corporation’s repliform tissue regeneration matrix, is implementing a recall on behalf of lifecell corporation. lifecell has informed boston scientific corporation that the incorrect ink was used in the manufacture of the printed backing component of the lots identified below. this could potentially lead to the transfer of ink from the printed backing component to the repliform tissue regeneration matrix and subsequent patient implantation. per lifecell’s toxicological analysis and health assessment, exposure to the chemicals found in the ink at the levels used is unlikely to pose a safety concern. if affected repliform matrix was implanted, there is a potential for a local transient inflammatory response. there are no identified long term health consequences. 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 14 may 2015.

Device

Repliform Tissue Regeneration Matrix
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medical Device Safety Alert
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH