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

Recall Z-1692-2017 — UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.

U.S. FDA — Device Enforcement · Taiwan · 2017-02-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1692-2017
Date of alert: 2017-02-10
Country / jurisdiction: Taiwan
Risk level: Class II
Risk type: recall
Brand: United Orthopedic Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 93045101

Reported risk: The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.

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.

Recall Z-1692-2017 — UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.

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