FDA (Devices) recall action 76629
The FDA (Devices) publishes a recall like this one as 35 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 35 pages.
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
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 sterile porous femoral stems because packaging design verification tests failed. The action affects units distributed worldwide.
Zimmer Biomet is recalling sterile intramedullary nail implants and accessories because packaging design verification tests failed.
Zimmer Biomet is recalling sterile porous femoral stems because packaging design verification tests failed. The recall affects units distributed worldwide.
Zimmer Biomet is recalling 9,867 sterile intramedullary rods and accessories due to packaging design verification test failures.
Zimmer Biomet is recalling sterile intramedullary nail implants because packaging design verification tests failed. The action covers specific lots distributed worldwide.
Zimmer Biomet is recalling 9,867 sterile femoral intramedullary nails because packaging design verification tests failed. The recall affects units distributed worldwide.
Zimmer Biomet is recalling sterile femoral intramedullary nail implants due to packaging design verification test failures.
Zimmer Biomet is recalling sterile intramedullary nail implants because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.
Zimmer Biomet is recalling 9,867 sterile hip implants because packaging design verification tests failed. The recall covers units distributed worldwide.
Zimmer Biomet is recalling sterile femoral intramedullary nails because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.