Klassic BiPolar Head recall — FDA Z-0432-2026
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.
Overview of recall records associated with Total Joint Orthopedics, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
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.
This page summarizes recall records in which the official source identifies Total Joint Orthopedics, 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.