FDA (Devices) recall action 80534
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.
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
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 12 Echo Bi-Metric Hip Stems because they may have been mixed with a different model. The error could extend surgery time.
Zimmer Biomet is recalling 12 ARCOS Modular Revision Hip System femoral stems because they may have been mixed with Echo BI-Metric stems, potentially extending surgery time.