RegWardenFDA facility compliance records
Recall

Class II — Arthrosurface, Inc.

Recalling firmArthrosurface, Inc.
Registered facilityARTHROSURFACE, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonFully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
ProductArthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Quantity136
DistributionWorldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Initiated2014-11-24
Classified2015-02-12
Terminated2015-03-27
Recall numberZ-1110-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Arthrosurface, Inc. (Z-1110-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69723/

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