Arthrosurface, Inc.: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.

Agency Publication Date: February 12, 2015

Affected Products

Product: Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.

Catalog Number: 6105-0028, Part Number 1105-0028

Product: 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.

Catalog Number: 6125-0035, Part Number: 1125-0035

Product: 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.

Catalog Number: 8135-0032, Part Number: 3135-0032

Product: 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.

Catalog Number: 8135-1875 Part Number: 3135-1875

Product: 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.

Catalog Number: 8156-0032, Part Number: 156-0032

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69723

Status: Resolved

Manufacturer: Arthrosurface, Inc.

Manufactured In: United States

Units Affected: 5 products (136; 143; 138; 182 units; 187)

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Sources: FDA iRES · Raw API Response

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