Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0432-2026 — Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028

U.S. FDA — Device Enforcement · United States · 2025-09-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0432-2026
Date of alert: 2025-09-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Total Joint Orthopedics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00814703011931

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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