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Showing 87201–87220 of 92420 results

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BIOMERIEUX, INC.: Bac T/ALERT 3D 60

A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.

FDAMay 27, 2005Nationwide• BIOMERIEUX, INC.

Warsaw Orthopedic, Inc.: Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusi...

The product is labeled as sterile, but this lot was not sterilized.

FDAMay 27, 2005Nationwide• Warsaw Orthopedic, Inc.

BIOMERIEUX, INC.: Bac T/ALERT 3D Control Module

A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.

FDAMay 27, 2005Nationwide• BIOMERIEUX, INC.

Stryker Howmedica Osteonics Corp.: Triathlon Femoral Sizer - The Femoral sizer was developed...

Stryker Orthopaedics became aware that when attempting to position the Triathlon Femoral Sizer, the pre-setting may slip from l (left knee) to R (right knee) and vice verse intraoperatively.

FDAMay 27, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E knee system, all polyethylene curved tibia...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy Preservation Uni Knee All Poly Tibial; polyethylene...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. SIGMA curved insert; polyethylene tibial ins...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. SIGMA RPF tibial insert; polyethylene tibial...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E RP Knee System, rotating platform stabiliz...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. E Knee System, stabilized all-polyethylene t...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy LCS Complete RP insert; polyethylene tibial insert ...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Ortho-Clinical Diagnostics: Vitros Chemistry CRBM Slides, REF 889 2382. There are 90...

Falsely elevated Carbamazepine results.

FDAMay 26, 2005Nationwide• Ortho-Clinical Diagnostics

Diagnostic Products Corp: Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LK...

Adverse trend in stability, controls biased or out of range.

FDAMay 26, 2005Nationwide• Diagnostic Products Corp

Depuy Orthopaedics, Inc.: Depuy P.F.C. E knee system, TC3 tibial insert; polyethyle...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy P.F.C. Modular Knee System, curved tibial insert (C...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy SIGMA curved plus insert; polyethylene tibial inser...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Depuy Orthopaedics, Inc.: Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz...

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

FDAMay 26, 2005Nationwide• Depuy Orthopaedics, Inc.

Toshiba American Med Sys Inc: Magnetic Resonance Imaging Systems; Visart, Excelart / E...

Patient information A is displayed with images for patient B.

FDAMay 25, 2005Nationwide• Toshiba American Med Sys Inc

Becton Dickinson & Company: BD Syringes - #309585 -- Piston Syringe, Syringe 3ML LL...

The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.

FDAMay 25, 2005Nationwide• Becton Dickinson & Company

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