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Manufacturers
Arthrosurface, Inc.
Manufacturer Address
Arthrosurface, Inc., 28 Forge Pkwy, Franklin MA 02038
Manufacturer Parent Company (2017)
ArthroSurface
Source
USFDA
6 Events
Recall of Device Recall Arthrosurface ToeMotion"
Recall of Device Recall The HemiCAP Contoured Articular Prosthetic
Recall of Device Recall The HemiCAP Contoured Articular Prosthetic
Recall of Device Recall The HemiCAP Contoured Articular Prosthetic
Recall of Device Recall The HemiCAP Contoured Articular Prosthetic
Recall of Device Recall The HemiCAP Contoured Articular Prosthetic
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6 devices in the database
Device Recall Arthrosurface ToeMotion"
Model / Serial
SN 000242 SN 000244 SN 000246 SN 000247
Product Classification
Orthopedic Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
US Distribution to the states of : PA, WV and CA.
Product Description
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
Model / Serial
Catalog Number: 8156-0032, Part Number: 156-0032
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Product Description
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
Model / Serial
Catalog Number: 8135-1875 Part Number: 3135-1875
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Product Description
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
Model / Serial
Catalog Number: 8135-0032, Part Number: 3135-0032
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Product Description
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
Model / Serial
Catalog Number: 6125-0035, Part Number: 1125-0035
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Product Description
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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