FDA Medical Device Recalls (openFDA)
Arthrosurface, Inc.: 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.
- Recall number
- Z-1113-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-11-24
- Posted
- 2015-02-12
- Terminated
- 2015-03-27
- Reason
- Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- 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 RA@arthrosurface.com. For questions regarding this recall call 508-528-4604.
- Quantity
- 182 units
- Distribution
- Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
- Lot, serial or model codes
- Catalog Number: 8135-1875 Part Number: 3135-1875
- 510(k) numbers
- ["K023096"]
- PMA numbers
- not on file
- Product code
- HSD
- Firm FEI
- 3004154314
- Firm city
- Franklin
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28