Recall database

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-0432-2026

Total Joint Orthopedics, Inc. recalls Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar…

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Cemented Or Uncemented Metal/Polymer Femoral Hemi- Hip Prosthesis
Packaging

Total Joint Orthopedic…UTNov 12, 2025

Class IIOngoingZ-0150-2026

BioPro, Inc. recalls BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR H…

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Cemented Or Uncemented Metal/Polymer Femoral Hemi- Hip Prosthesis
Package design/selection

BioPro, Inc.MIOct 22, 2025