FDA (Devices) recall action 83314
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Cleaning processes potentially being ineffective
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 30 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective.
Zimmer Biomet is recalling 19 units of Orthopedic Salvage System Hybrid Poly Tibia components because cleaning processes may be ineffective.
Zimmer Biomet is recalling 39 units of the Orthopedic Salvage System Hybrid Poly Tibia due to potentially ineffective cleaning processes.
Zimmer Biomet is recalling 23 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The products were distributed to 18 US states, Japan, and the Netherlands.
Zimmer Biomet is recalling 28 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The products were distributed in the US and internationally.
Zimmer Biomet is recalling 29 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The recall covers units distributed in the US, Japan, and the Netherlands.