Biomet Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex recall — FDA Z-2146-2020
Potential presence of elevated endotoxin levels that exceed the specification limit
Overview of recall records associated with Biomet, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 135.
Potential presence of elevated endotoxin levels that exceed the specification limit
Potential presence of elevated endotoxin levels that exceed the specification limit
There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
This page summarizes recall records in which the official source identifies Biomet, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.