FDA (Devices) recall action 80904
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.
The implant only has one bolt in the sterile package but it should have had two.
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 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained one bolt instead of the required two.
Zimmer Biomet is recalling 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained only one bolt instead of the required two.