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Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Nu...

FDA Recall #Z-1111-2015 — Class II — November 24, 2014

Recall #Z-1111-2015 Date: November 24, 2014 Classification: Class II Status: Terminated

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.

Reason for Recall

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

Recalling Firm

Arthrosurface, Inc. — Franklin, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

143

Distribution

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

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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