FDA (Devices) recall action 79146
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
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 337 femoral intramedullary nail loaner kits because the bolt connecting the insertion guide to the nail can fracture during insertion.
Zimmer Biomet is recalling 337 Phoenix Antegrade Femoral Nail Connecting Bolts because the bolt may fracture during insertion of the femoral nail.
Zimmer Biomet is recalling 337 Antegrade Femoral Nail Instrument Kits because a bolt may fracture during use, potentially affecting patients undergoing orthopedic surgery.