Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System… — Class II medical device recall Z-0994-2014
Terminated recall by Integra LifeSciences Corp., reported 2014-02-26, distributed nationwide. The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
| Recall number | Z-0994-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2013-12-05 |
| Classified | 2014-02-19 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2017-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 17,253 boxes |
| Model numbers | 1083655, 1084216, 1084219, 1084293, 1084377, 1084398, 1084399, 1084400, 1084680, 1084681, 1084682, 1084683, 1090123, 1090124, 1090125, 1090126, 1090660, 1090661, 1090826, 1090937, 1091395, 1091434, 1091700, 1091712, 1091714 and 276 more |
Product
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 waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
Reason for recall
The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0994-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.