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Arthrosurface, Inc. recalls Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP
Recalled February 18, 2015 · FDA recall Z-1112-2015 · Arthrosurface
Hazard
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. · FDA Class II
Units
138
Sold at
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Description
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
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.
Manufacturer(s)
Arthrosurface, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →