Klassic BiPolar Head recall — FDA event 97708
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.
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The FDA identifies Total Joint Orthopedics, Inc. as the recalling firm in one or more MedWatcher-reviewed medical-device recall records.
This page includes only canonical device families and FDA recall events separately reviewed for publication by MedWatcher. It is not a complete product catalogue.
Canonical identity is based on the linked official product, UDI, or FDA recalling-firm source. Source-name variants are retained as aliases rather than separate manufacturer pages.
Source databases can use a legal name, brand, division, or shortened name. MedWatcher retains the form used as evidence rather than treating every similar name as the same manufacturer.
Page reviewed Aug 17, 2026 by MedWatcher project owner — FUS-265 · Next review by Nov 15, 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.