Reported Feb 26, 2014 · Terminated

Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel +…

Integra LifeSciences Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344

Is this the product you have?

  • Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿
  • Excel System Product UsageIntended 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
Lot codes and dates
  • All unexpired lot numbers for CEM Nosecone Gatalouge No. C6623 and C6636 from 1/1/2010 to present. CEM" Nosecone, Catalogue No
  • C6623

    106 of 106 codes

    • 1083655
    • 1084219
    • 1084398
    • 1084399
    • 1084400
    • 1084682
    • 1084683
    • 1090937
    • 1091712
    • 1091714
    • 1091715
    • 1093125
    • 1093126
    • 1093128
    • 1093129
    • 1093471
    • 1093847
    • 1094575
    • 1094740
    • 1095587
    • 1095873
    • 1100237
    • 1100238
    • 1101217
    • 1101547
    • 1101548
    • 1102069
    • 1102070
    • 1102544
    • 1102545
    • 1102546
    • 1103102
    • 1103392
    • 1103444
    • 1103445
    • 1103446
    • 1104264
    • 1104265
    • 1105065
    • 1105066
    • 1105067
    • 1110208
    • 1110311
    • 1110348
    • 1110349
    • 1110473
    • 1110474
    • 1110892
    • 1111760
    • 1112182
    • 1112808
    • 1112809
    • 1113175
    • 1113176
    • 1113177
    • 1113178
    • 1113662
    • 1114112
    • 1114654
    • 1114655
  • C6636

    215 of 215 codes

    • 1084216
    • 1084293
    • 1084377
    • 1084680
    • 1084681
    • 1090123
    • 1090124
    • 1090125
    • 1090126
    • 1090660
    • 1090661
    • 1090826
    • 1091395
    • 1091434
    • 1091700
    • 1092388
    • 1092389
    • 1092390
    • 1092391
    • 1092392
    • 1093012
    • 1093013
    • 1093130
    • 1093131
    • 1093472
    • 1093473
    • 1093474
    • 1093824
    • 1093825
    • 1093826
    • 1093827
    • 1094741
    • 1095104
    • 1095105
    • 1095106
    • 1095414
    • 1095415
    • 1095418
    • 1095419
    • 1100239
    • 1100240
    • 1100241
    • 1101220
    • 1101221
    • 1102647
    • 1102648
    • 1102649
    • 1102650
    • 1102651
    • 1103103
    • 1103394
    • 1103395
    • 1103437
    • 1103848
    • 1103851
    • 1103916
    • 1103917
    • 1103919
    • 1103920
    • 1103921
Amount recalled
17253 boxes

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 26, 2017 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.