Medical DeviceNov 8, 2023
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum recall — FDA Z-0211-2024
Reports were received the elastomer cup material is crumbling.
Class IIFDA: OngoingCosmedent, Inc.
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceMar 7, 2018
Cosmedent recall — FDA Z-0741-2018
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Class IIFDA: TerminatedCosmedent, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Cosmedent, 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.