FDA (Devices) recall action 85153
The FDA (Devices) publishes a recall like this one as 33 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 33 pages.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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.
Biomet, Inc. is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet, Inc. is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.
Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet, Inc. is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.
Biomet is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet, Inc. is recalling StageOne Hip Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.
Biomet is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.
Biomet is recalling StageOne Knee Femoral Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet, Inc. is recalling specific lots of Custom StageOne Hip Femoral Reinforcement due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet, Inc. is recalling StageOne Hip Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.
Biomet, Inc. is recalling 230,001 units of StageOne Knee Femoral Cement Spacer Molds due to potentially insufficient cleaning or inadequate process monitoring.
Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.
Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes and inadequate process monitoring.
Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet is recalling hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet, Inc. is recalling BIOMET StageOne Knee Femoral Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.
Biomet, Inc. is recalling specific lots of StageOne Select Hip Stem Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.