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FAQ
Crédits
Manufacturers
Arthrosurface, Inc.
Adresse du fabricant
Arthrosurface, Inc., 28 Forge Pkwy, Franklin MA 02038
Société-mère du fabricant (2017)
ArthroSurface
Source
USFDA
6 Events
Rappel de Device Recall Arthrosurface ToeMotion"
Rappel de Device Recall The HemiCAP Contoured Articular Prosthetic
Rappel de Device Recall The HemiCAP Contoured Articular Prosthetic
Rappel de Device Recall The HemiCAP Contoured Articular Prosthetic
Rappel de Device Recall The HemiCAP Contoured Articular Prosthetic
Rappel de Device Recall The HemiCAP Contoured Articular Prosthetic
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6 dispositifs dans la base de données
Device Recall Arthrosurface ToeMotion"
Modèle / numéro de série
SN 000242 SN 000244 SN 000246 SN 000247
Classification du dispositif
Orthopedic Devices
Classe de dispositif
Unclassified
Dispositif implanté ?
Yes
Distribution
US Distribution to the states of : PA, WV and CA.
Description du dispositif
Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 || The component in question is the hex driver (part number 2009-4001).
Device Recall The HemiCAP Contoured Articular Prosthetic
Modèle / numéro de série
Catalog Number: 8156-0032, Part Number: 156-0032
Classification du dispositif
Orthopedic Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Description du dispositif
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Device Recall The HemiCAP Contoured Articular Prosthetic
Modèle / numéro de série
Catalog Number: 8135-1875 Part Number: 3135-1875
Classification du dispositif
Orthopedic Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Description du dispositif
Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Device Recall The HemiCAP Contoured Articular Prosthetic
Modèle / numéro de série
Catalog Number: 8135-0032, Part Number: 3135-0032
Classification du dispositif
Orthopedic Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Description du dispositif
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Device Recall The HemiCAP Contoured Articular Prosthetic
Modèle / numéro de série
Catalog Number: 6125-0035, Part Number: 1125-0035
Classification du dispositif
Orthopedic Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Description du dispositif
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
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