Tepha GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for recall — FDA Z-0948-2017
Endotoxin values from testing of retains slightly exceeded the established specification.
Overview of recall records associated with Tepha Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Endotoxin values from testing of retains slightly exceeded the established specification.
This page summarizes recall records in which the official source identifies Tepha 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.