Z-1113-2015Class II

Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875...

Name: Z-1113-2015 Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875...
Creator: Arthrosurface, Inc.
Published: 2014-11-24
License: https://open.fda.gov/license/

Arthrosurface, Inc. / initiated 2014-11-24 / Terminated

FDA source

Arthrosurface, Inc. began a recall of Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for... on 2014-11-24. FDA classified it as Class II and gives the reason as "Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1113-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-24
Posted: 2015-02-12
Terminated: 2015-03-27
Recalling firm: Arthrosurface, Inc.
Product: Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Product code: HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Reason for recall: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
FDA root cause: No Marketing Application
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.
Quantity in commerce: 182 units
Distribution: Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Product codes and lots: Catalog Number: 8135-1875 Part Number: 3135-1875

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1113-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1110-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-12
Z-1111-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-12
Z-1112-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-12
Z-1113-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-12
Z-1114-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-12

Product code HSD

K023096Class IIContoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. / cleared 2003-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)