Events

Safety Alert for Absorbable Collagen Sponge

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

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
    2013-06-13
  • Event Date Posted
    2013-06-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130613a.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: integra lifesciences absorbable collagen sponge medical device manufacturer, integra lifesciences corporation, has issued a medical device safety alert concerning certain lots of the absorbable collagen sponge (acs) which is a component of the infuse bone graft kit [model no.: 7510050, 7510100, 7510200, 7510800]. the manufacturer had identified through an internal quality assurance review of processes that may have deviated from a production process during the manufacturer of specific lots of products. the products lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to the process deviation, they may have been released with higher level of endotoxins than permitted by the specifications for the products. higher endotoxin levels may result in a fever in the immediate postoperative period. the manufacturer is not aware of any reports of patient injuries or other adverse events in connection with these product lots. the manufacturer recommends affected healthcare professionals to monitor their patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol. the manufacturer also advises all affected users to discontinue use of the captioned products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 jun 2013.

Device

Absorbable Collagen Sponge

Manufacturer

Integra LifeSciences Corporation