Axonics Modulation Technologies BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing recall — FDA Z-2077-2021
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Overview of recall records associated with Axonics Modulation Technologies, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
This page summarizes recall records in which the official source identifies Axonics Modulation Technologies, 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.