FDA (Devices) recall action 83594
The FDA (Devices) publishes a recall like this one as 35 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 35 pages.
The locking bar not fully engaging
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 Vanguard XP Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 498 XP-CR Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 327 units of XP-CR Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 86 units of the XP-XP Tibial Tray because the locking bar may not fully engage. The recall covers units distributed across the US and several international regions.
Zimmer Biomet is recalling 43 units of Vanguard XP Tibial Tray 65 mm because the locking bar may not fully engage.
Zimmer Biomet is recalling 123 units of Vanguard XP Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 375 units of the XP-CR Tibial Tray - Interlok 65mm because the locking bar may not fully engage.
Zimmer Biomet is recalling 1,210 units of the XP-XP Tibial Tray because the locking bar may not fully engage.
Zimmer Biomet is recalling 8 units of Vanguard XP Tibial Trays because the locking bar may not fully engage.
Zimmer Biomet is recalling 319 units of XP-CR Tibial Trays because the locking bar may not fully engage.