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Showing 62681–62700 of 68218 results

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Stryker Howmedica Osteonics Corp.: Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-...

Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.

FDAJan 25, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Biogenex Laboratories: Xmatrx FISH (fluorescent in situ hybridization) Automated...

Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.

FDAJan 24, 2008Nationwide• Biogenex Laboratories

California Medical Laboratories Inc: CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Si...

Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

FDAJan 24, 2008Nationwide• California Medical Laboratories Inc

California Medical Laboratories Inc: CalMed Malleable Pericardial Sump, Single Use Only. Do No...

Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

FDAJan 24, 2008Nationwide• California Medical Laboratories Inc

B & K Medical Systems, Inc.: B-K Medical Intraoperative Transducer Type 8814, diagnost...

Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.

FDAJan 24, 2008MA, MI, OR +2 more• B & K Medical Systems, Inc.

Cardiac Science Corporation: 9051 Electrode Adapter; Automated external defibrillator,...

Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.

FDAJan 23, 2008Nationwide• Cardiac Science Corporation

Cardiac Science Corporation: Electrode Adaptor Cable Quick-Combo System, Model 9055 Th...

Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.

FDAJan 23, 2008Nationwide• Cardiac Science Corporation

Cybernet Systems Corp.: Cybernet Medical MedStar Telemedicine System, Manufacture...

A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.

FDAJan 23, 2008Nationwide• Cybernet Systems Corp.

Stryker Howmedica Osteonics Corp.: Trident Hemispherical Solid BK Acetabular Shells; 42mm to...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Abbott Laboratories: AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; L...

Laceration Risk

Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.

FDAJan 21, 2008PR• Abbott Laboratories

Stryker Howmedica Osteonics Corp.: Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposite...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident Hemispherical Multi Arc Deposited; Hydroxylapat...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident PSL HA Cluster: 40 mm to 72 mm, hip prosthesis c...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident Hemispherical HA Cluster, 42 mm - 74mm Arc Depos...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident Hemispherical Acetabular Shells HA Solid BK 42mm...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident PSL Acetabular Shells; Trident PSL HA Solid Back...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Unknown Manufacturer: ev3 IntraStent LD Mega Large Diameter Biliary Stent, Mode...

Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.

FDAJan 18, 2008Nationwide

Radiometer America Inc: ABL700 Series analyzer - Human Blood Analyzer (Laboratory...

Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.

FDAJan 18, 2008IN• Radiometer America Inc

Otsuka America Pharmaceutical, Inc.: UBiT-IR300 Infrared Spectrophotometer, Software Versions ...

Medical device power supply may overheat and cause smoke to be emitted from the device.

FDAJan 18, 2008Nationwide• Otsuka America Pharmaceutical, Inc.

Unknown Manufacturer: ev3 IntraStent LD Max Large Diameter Biliary Stent, Model...

Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.

FDAJan 18, 2008Nationwide

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