Arthrosurface 25&30mm 10 — Class II medical device recall Z-1110-2015
Terminated recall by Arthrosurface, Inc., reported 2015-02-18, distributed nationwide. Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
| Recall number | Z-1110-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrosurface, Inc., Franklin, MA, United States |
| Recall initiated | 2014-11-24 |
| Classified | 2015-02-12 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2015-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 136 |
| Reason classes | unapproved product |
| Model numbers | 1105-0028, 6105-0028 |
Product
Arthrosurface 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.
Reason for recall
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1110-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.