FDA (Devices) recall action 74038
The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
The agency’s own wording, quoted from the enforcement report.
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility.
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility.
Biomet is recalling various trauma, sports medicine, and spinal implants because insufficient seal strength may compromise sterility, potentially leading to infection.
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility.
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility.
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Biomet is recalling various trauma and sports medicine instruments and arthroscopes because insufficient seal strength on sterile packaging could allow the product to become nonsterile.
Biomet, Inc. is recalling specific trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility and lead to infection.