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Showing 20401–20420 of 22584 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.

B. Braun Medical, Inc.: Locking Tear-Away Sheath Introducer Product Line. ACCUG...

Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.

FDAMay 27, 2005IN• B. Braun Medical, 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.

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.

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.

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

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 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.

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. 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.

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. 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. 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 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. 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 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 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.

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

Falsely elevated Carbamazepine results.

FDAMay 26, 2005Nationwide• Ortho-Clinical Diagnostics

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.

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