FDA (Devices) recall action 70401
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Zimmer GmbH is recalling 1,908 CoCr Femoral Heads due to potential sterile tray compromise. Undetected breaches could lead to contamination and periprosthetic infection.
Zimmer GmbH is recalling 6,109 CoCr femoral heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.
Zimmer GmbH is recalling 10,340 BIOLOX delta Ceramic Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection.
Zimmer GmbH is recalling 30 Metasul Femoral Head units due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.
Zimmer GmbH is recalling 16 Metasul Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.