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

Recall Z-0994-2014 — Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation

U.S. FDA — Device Enforcement · United States · 2013-12-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0994-2014
Date of alert: 2013-12-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Integra LifeSciences Corp.
Product category: device
Product type: Devices

Reported risk: The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.

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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