FDA (Devices) recall action 84224
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.
Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
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 34 units of 14MM Intramedullary Bone Saw Cam Assemblies because some were labeled as 14MM but measured as 13MM.
Zimmer Biomet is recalling 26 units of 13MM Intramedullary Bone Saw Cam Assemblies due to possible commingling with 14MM units.