Recall Z-1112-2015— Arthrosurface, Inc.

Name: FDA recall Z-1112-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-24

Class II · Terminated

Class II FDA medical device recall by Arthrosurface, Inc., initiated 2014-11-24, terminated 2015-03-27. It names one FDA 510(k) clearance: K023096. 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.. Reason: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications..

Recalling firm: Arthrosurface, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-24
Terminated: 2015-03-27
Firm location: Franklin, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K023096 — CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEMStd Mfg., Inc.·cleared 2003-04-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.