FDA (Devices) recall action 93830
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
The agency’s own wording, quoted from the enforcement report.
Howmedica Osteonics Corp. is recalling hip arthroplasty surgical instruments after their sterile packaging failed integrity testing. Units with compromised packaging were distributed worldwide.
Howmedica Osteonics is recalling HRIS ACET CUP surgical instruments used in hip replacement surgery due to failed package seal integrity testing. The recall affects lot-numbered units distributed worldwide.