FDA (Devices) recall action 82004
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.
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
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 Biomet is recalling 45 Vanguard Knee System patella components because a potential commingle may cause the implant size to not match the label.
Zimmer Biomet is recalling 90 Vanguard Knee System patella implants because a potential commingle could result in the implant size not matching the label.