Arthrosurface, Inc. recalls Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP C…

Recall date

November 24, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1113-2015

FDA classification

Class II

Brand / firm

Arthrosurface, Inc.

Sold / distributed

Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.