FDA (Devices) recall action 82818
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.
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
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 15 Oxford Partial Knee drill guides because incorrect raw materials may cause the screw component to corrode.
Zimmer Biomet is recalling 3 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw materials may cause corrosion.
Zimmer Biomet is recalling 10 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used, potentially leading to corrosion.
Zimmer Biomet is recalling 14 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw materials were used, potentially leading to corrosion.
Zimmer Biomet is recalling 41 Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used in the screw component, which could lead to corrosion.
Zimmer Biomet is recalling 11 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used, potentially leading to corrosion.