Howmedica Osteonics TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision recall — FDA Z-1631-2024
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Overview of recall records associated with Howmedica Osteonics Corp., including dates, categories and classifications where available.
Classification mix: Class II: 223, Class III: 2.
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising…
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising…
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
This page summarizes recall records in which the official source identifies Howmedica Osteonics Corp. 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.