FDA (Devices) recall action 83099
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.
Lack of an adequate sterilization validation.
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 1,257 Comprehensive Reverse Shoulder Instrument Cases because they lack adequate sterilization validation. The products were distributed in the US and 16 foreign countries.
Zimmer Biomet is recalling 92 Comprehensive Reverse Shoulder Instrument Cases because they lack adequate sterilization validation. The products were distributed in the US and 16 foreign countries.