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Showing 64601–64620 of 68218 results

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Zimmer Inc.: Zimmer Trabecular metal primary hip prosthesis femoral st...

Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

FDAAug 2, 2006Nationwide• Zimmer Inc.

Zimmer Inc.: Zimmer ZMR Hip System femoral body, revision, nitrided, p...

Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

FDAAug 2, 2006Nationwide• Zimmer Inc.

Zimmer Inc.: Zimmer VERSYS Hip System Femoral Stem, press-fit, enhance...

Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

FDAAug 2, 2006Nationwide• Zimmer Inc.

Stryker Howmedica Osteonics Corp.: T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker...

The thread of the nut which should fix the nail adaptor to the targeting arm may seize on the threat of the nail adaptor, interrupting surgery.

FDAAug 2, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Zimmer Inc.: Zimmer MAYO Conservative hip prosthesis femoral stem, por...

Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

FDAAug 2, 2006Nationwide• Zimmer Inc.

Elekta, Inc.: Leksell Gamma Knife C

Due to a material change in a critical component of the linear actuators the quality of said part was found to be inadequate.

FDAAug 1, 2006AL, CA, CO +20 more• Elekta, Inc.

Medtronic Sofamor Danek Instrument Manufacturing: Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofa...

Laceration Risk

Bone reamer may not have a cutting surface on the tip.

FDAAug 1, 2006Nationwide• Medtronic Sofamor Danek Instrument Manufacturing

Trionix Research Laboratory Inc: BIAD Classic 24 (24 inch collimator). The collimator is a...

The ball screw on the unit which supports the detector head (which weighs approximately 800 lbs.) could snap resulting in the detector head dropping on the patient.

FDAAug 1, 2006Nationwide• Trionix Research Laboratory Inc

ConvaTec: ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch wi...

Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label.

FDAJul 31, 2006Nationwide• ConvaTec

Beckman Coulter Inc: UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Pa...

The neck of the wash buffer cube can be extended higher than intended possibly causing the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. This may lead to incorrect assay results.

FDAJul 28, 2006Nationwide• Beckman Coulter Inc

Haemonetics Corporation: SmartSuction Harmony Powered Suction Device Model Number:...

Faulty circuit board may short circuit and cause electric shock to operator

FDAJul 28, 2006AZ, CT, GA +2 more• Haemonetics Corporation

Hill-Rom, Inc.: Hill-Rom VersaCare Hospital Bed with optional patient pen...

The patient pendant cord represents a potential trip hazard for the patient or the caregiver.

FDAJul 27, 2006Nationwide• Hill-Rom, Inc.

Beckman Coulter Inc: Cytomics FC 500 Flow Cytometry System with CXP Software V...

Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition.

FDAJul 26, 2006Nationwide• Beckman Coulter Inc

Roche Diagnostics Corp.: Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; ...

The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results)

FDAJul 25, 2006Nationwide• Roche Diagnostics Corp.

Ciba Vision Corporation: Focus * DAILIES * Toric * One-Day Contact Lenses * CIBA V...

Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50) .

FDAJul 25, 2006Nationwide• Ciba Vision Corporation

EMD Chemicals Inc: Histochemical PAS (Periodic Acid Schiff) Reaction Set. i...

Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly.

FDAJul 25, 2006Nationwide• EMD Chemicals Inc

Becton Dickinson & Company: BD 1mL SafetyGlide Allergy and Tuberculin Syringes. Reor...

BD received reports of needle assembly disengagement from the syringe.

FDAJul 24, 2006Nationwide• Becton Dickinson & Company

Philips Medical Systems: IntelliVue MultiMeasurement Server (MMS)/Multimeasurement...

Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached

FDAJul 24, 2006Nationwide• Philips Medical Systems

Exactech, Inc.: AcuMatch M-Series Straight Fluted Stem Segment and AcuMat...

The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.

FDAJul 21, 2006AL, IN• Exactech, Inc.

Cordis Corporation: CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Gui...

Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.

FDAJul 21, 2006PR• Cordis Corporation

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