Merz COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of recall — FDA Z-0401-2021
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Overview of recall records associated with Merz North America, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
This page summarizes recall records in which the official source identifies Merz North America, 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.