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.
FDA Recall Z-1112-2015 · Posted 2015-02-12
Recalling FirmArthrosurface, Inc.
Recall StatusTerminated
Product CodeHSD
Date Initiated2014-11-24
Date Terminated2015-03-27
Product Quantity138
Reason for Recall
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Firm Action
Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email [email protected]. For questions regarding this recall call 508-528-4604.
Root Cause
No Marketing Application
Distribution Pattern
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.