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

Recall Z-0227-2026 — iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-

U.S. FDA — Device Enforcement · United States · 2025-09-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0227-2026
Date of alert: 2025-09-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Theken Companies LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00816127029431

Reported risk: Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

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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