FDA (Devices) recall action 75970
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.
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
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 19 ArComXL Polyethylene Bearings because packaging labels did not match the physical product inside, posing a risk of surgical delay.
Zimmer Biomet is recalling 36 units of ArComXL polyethylene liners because packaging labels did not match the physical product, posing a risk of surgical delay.