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Compress Face Reamer (Biomet) – Missing Helix Angle (2014)

Investigation determined that units supplied were missing the 4x21 degree helix angle.

FDASep 17, 2014IN• Biomet, Inc.

EndoWrist Vessel Sealer (Intuitive Surgical) – Labeling Correction (2014)

Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.

Class IIModerate

FDASep 17, 2014Nationwide• Intuitive Surgical, Inc.

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Compress Face Reamer (Biomet) – Missing Helix Angle (2014)

EndoWrist Vessel Sealer (Intuitive Surgical) – Labeling Correction (2014)

Cranberry Macaroon Granola (NatureBox) – Incorrect Label (2014)

TELIGEN Cardiac Defibrillator (Boston Scientific) – Battery Issue (2014)

COGNIS CRT-D Defibrillator (Boston Scientific) – Battery Depletion (2014)

Artis zee Zeego System (Siemens) – X-Ray Tube Failure (2014)

ZOLL Pro-padz Electrodes (Bio-Detek) – Sterility Issue (2014)

ZOLL Pro-padz Electrodes (Bio-Detek) – Sterility Problem (2014)

ZOLL Pro-padz Electrodes (Bio-Detek) – Sterility Risk (2014)

ZOLL Pro-padz Electrodes (Bio-Detek) – Sterility Risk (2014)

CREON (AbbVie) – Foreign Tablets Mixed (2014)

ADVIA Centaur HBc Total Kit (Siemens) – Imprecision Risk (2014)

Lumbar Drainage Catheter Kit (Codman) – CSF Drainage Issue (2014)

Tarceva (Astellas) – Dissolution Specification Failure (2014)

Topiramate (Zydus) – Tablet Mix-up (2014)

OEC Brivo 715 Mobile C-Arm (GE) – X-Ray Accuracy Problem (2014)

Anesthesia Conduction Catheter (Arrow) – Component Error (2014)

OEC Brivo 865 Mobile C-Arm (GE) – X-Ray Accuracy Issue (2014)

EDS 3 Drainage System (Codman) – CSF Drainage Risk (2014)

ADVIA Centaur HBc Total Reagent (Siemens) – Imprecision Problem (2014)