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Crédits
Devices
Beuchal Pappas Mobile Bearing Knee System
Modèle / numéro de série
LOT #'s: 04331022ANN286, 04331023ANN286, 04331024ANN286, 04331025ANN286, 04331026ANN286.
Classification du dispositif
Orthopedic Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
Description du dispositif
"***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec, Inc. 20 Valley Street South Orange NJ, 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking, Surrey GU213BA England Tel (0)1483-721404***" || Size: || 04-33-1022 Modular Tibial Bearing 2 x 5 || 04-33-1023 Modular Tibial Bearing 3 X 5 || 04-33-1024 Modular Tibial Bearing 4 X 5 || 04-33-1025 Modular Tibial Bearing 5 X 5 || 04-33-1026 Modular Tibial Bearing 6 X 5. || Tricompartmental Knee Replacement
Manufacturer
Endotec, Inc.
1 Event
Rappel de Beuchal Pappas Mobile Bearing Knee System
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Fabricant
Endotec, Inc.
Adresse du fabricant
Endotec, Inc., 300 Sunport Ln Ste 500, Orlando FL 32809-8123
Société-mère du fabricant (2017)
Cellumed Co., Ltd.
Source
USFDA
12 dispositifs médicaux avec un nom similaire
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Beuchal Pappas Mobile Bearing Knee System
Modèle / numéro de série
04330001Z001NN435 04330001Z005NN436 K04330002A1NN459 K04330002A2NN712 04330003ONN700 04330004NNN462 K04330004B1NN702 04330005Z001NN435 04330005NNN459 K04330005AANN733 04330005AANN736 04330005ABNN751 04330006Z001NN437 04330006H1NN749
Classification du dispositif
Orthopedic Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
Description du dispositif
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" || SIZE 1 x 0mm CAT 04-33-0001; || SIZE 2 x 0mm CAT 04-33-0002; || SIZE 3 x 0mm CAT 04-33-0003; || SIZE 4 x 0mm CAT 04-33-0004; || SIZE 5 x 0mm CAT 04-33-0005; || SIZE 6 x 0mm CAT 04-33-0006. || Tricompartmental Knee Replacement
Manufacturer
Endotec, Inc.
Beuchal Pappas Mobile Bearing Knee System
Modèle / numéro de série
04330011Z001NN436 K04330012A1NN712 K04330012A3NN720 04330012Z002NN443 K04330013A3NN720 K04330013A5NN750 04330014A1NN462 K04330014A1NN726 K04330014A2NN750 04330015Z005NN436 04330015Z001NN726 K04330015Z001-1NN453 04330015AANN752 04330016HNN749
Classification du dispositif
Orthopedic Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
Description du dispositif
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" || SIZE 1 x 2.5mm CAT 04-33-0011; || SIZE 2 x 2.5mm CAT 04-33-0012; || SIZE 3 x 2.5mm CAT 04-33-0013; || SIZE 4 x 2.5mm CAT 04-33-0014; || SIZE 5 x 2.5mm CAT 04-33-0015; || SIZE 6 x 2.5mm CAT 04-33-0016. || Tricompartmental Knee Replacement
Manufacturer
Endotec, Inc.
Beuchal Pappas Mobile Bearing Knee System
Modèle / numéro de série
K04330021A1NN703 K04330021Z002NN439 K04330022A1NN720 04330022Z1001NN439 K04330022A2NN750 K04330023A1NN720 04330023M2NN751 K04330024A1NN703 04330025AANN755 04330026HNN339 04330026FNN309 04330026HNN400
Classification du dispositif
Orthopedic Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
Description du dispositif
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" || SIZE 1 x 5mm CAT 04-33-0021; || SIZE 2 x 5mm CAT 04-33-0022; || SIZE 3 x 5mm CAT 04-33-0023; || SIZE 4 x 5mm CAT 04-33-0024; || SIZE 5 x 5mm CAT 04-33-0025; || SIZE 6 x 5mm CAT 04-33-0026. || Tricompartmental Knee Replacement
Manufacturer
Endotec, Inc.
Beuchal Pappas Mobile Bearing Knee System
Modèle / numéro de série
04330031Z001NN434 K04330031A1NN701 K04330031A2NN702 K04330032A1NN720 04330032Z001NN444 K04330032Z1001NN453 K04330033A1NN720 K04330033Z001NN450 K04330034A1NN703 04330034Z001NN442 04330035HNN398 04330035JNN398 04330036HNN338 04330036GNN321 04330036FNN309 04330036GNN400 04330036HNN400
Classification du dispositif
Orthopedic Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
Description du dispositif
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" || SIZE 1 x 7.5mm CAT 04-33-0031; || SIZE 2 x 7.5mm CAT 04-33-0032; || SIZE 3 x 7.5mm CAT 04-33-0033; || SIZE 4 x 7.5mm CAT 04-33-0034; || SIZE 5 x 7.5mm CAT 04-33-0035; || SIZE 6 x 7.5mm CAT 04-33-0036. || Tricompartmental Knee Replacement
Manufacturer
Endotec, Inc.
Beuchal Pappas Mobile Bearing Knee System
Modèle / numéro de série
K04330041A1NN467 K04330041A2NN741 K04330042A1NN467 K04330042A2NN467 K04330042A3NN741 K04330043A1NN467 K04330043A2NN467 K04330043A3NN741 K04330044A1NN467 K04330044A2NN741 K04330045A1NN742 K04330046A1NN742
Classification du dispositif
Orthopedic Devices
Classe de dispositif
3
Dispositif implanté ?
Yes
Distribution
USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
Description du dispositif
"***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" || SIZE 1 x 10mm CAT 04-33-0041; || SIZE 2 x 10mm CAT 04-33-0042; || SIZE 3 x 10mm CAT 04-33-0043; || SIZE 4 x 10mm CAT 04-33-0044; || SIZE 5 x 10mm CAT 04-33-0045; || SIZE 6 x 10mm CAT 04-33-0046. || Tricompartmental Knee Replacement
Manufacturer
Endotec, Inc.
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