496 results
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Sources: EU EUDAMED, US FDA
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Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485-3-318, and 6485-3-319. The Modular Replacement System has been successfully used in clinical in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These components can be used to replace the proximal femur, the distal femur, the proximal tibia, or to reconstruct the total femur in extreme clinical situations.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code KRO·January 30, 2009
Stryker Modular Replacement System Curved Cemented Stem; MRS 12mmx203 Femoral Stem. Catalog Number: 6485-3-313; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
Stryker Modular Replacement System Curved Cemented Stem; MRS 11mmx203mm femoral stem. Catalog Number: 6485-3-311; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
Stryker Modular Replacement System Curved Cemented Stem; MRS 15mmx203mm Femoral Stem. Catalog Number: 6485-3-315; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
Stryker Modular Replacement System Curved Cemented Stem; MRS 17mmx203 Femoral Stem. Catalog Number 6485-3-317; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
Stryker Modular Replacement System Curved Cemented Stem; MRS 11x127 Curved Femoral Stem. Catalog Number: 6485-3-711; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
Stryker Modular Replacement System Curved Cemented Stem; MRS 15x127 Curved Femoral Stem. Catalog Number: 6485-3-715; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
Stryker Modular Replacement System Curved Cemented Stem; MRS 17x127 Curved Femoral Stem. Catalog Number: 6485-3-717; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
Stryker Modular Replacement System Curved Cemented Stem; MRS 13x127 Curved Femoral Stem. Catalog Number: 6485-3-713; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 8x102. Catalog Number 6485-3-308; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem 10x102; Catalog Number: 6485-3-300; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 9 x 102. Catalog Number: 6485-3-309; Stryker Orthopaedics Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.
FDA Recall
Terminated
·Polymer Technology Systems, Inc.·Product code MRS·January 21, 2020
GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. The Global Modular Replacement System is intended to be used with the components of the Howmedica Osteonics Modular Replacement System , the Howmedica Osteonics Modular Rotating Hinge Knee System and/or the Howmedica Osteonics Kinematic Rotating Hinge Knee System in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMR may be used together, or with the components of the MRS, in replacement of the total femur.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code KRO·May 5, 2005
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.
FDA Recall
Terminated
·Baylis Medical Company Inc.·Product code DYB·October 7, 2019
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90.
FDA Recall
Terminated
·Baylis Medical Company Inc.·Product code DYB·October 7, 2019
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·May 16, 2018
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·May 16, 2018
G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·September 28, 2016
G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·September 28, 2016