FDA (Devices) recall action 79161
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.
Knee implant components (tibial bearings) are labeled with the incorrect size.
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 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size.
Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size. The components are intended for use in total knee arthroplasty.