Arthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues
Arthrosurface, Inc. is recalling 143 Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are assigned a score of 3 (High), as they represent a risk of harm where injury has not yet been reported.
Plain-English summary
Arthrosurface, Inc. is recalling 143 units of the Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component, Catalog Number 6125-0035, Part Number 1125-0035. These components are used in the HemiCAP Contoured Articular Prosthetic for humeral head resurfacing, an orthopedic shoulder prosthesis.
The recall was initiated because the fully threaded Taper Post Fixation components were not cleared for marketing in the United States with their current indications. The agency classification for this recall is Class II.
The affected products were distributed worldwide, including nationwide in the US and internationally to Europe, Canada, and Australia. However, the source text specifies that only products in the US are affected by this recall. Consumers and healthcare providers should stop using the affected components and contact Arthrosurface, Inc. for further instructions.
The recalled product
- Product
- Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
- Manufacturer
- Arthrosurface, Inc.
- Affected units
- 143
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number: 6125-0035
- Part Number: 1125-0035
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Arthrosurface, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Arthrosurface, Inc.
See all →- HighArthrosurface Total Toe Instrument Kit Recalled for Sterilization Failure
FDA (Devices) · 2015-12-30
- ModerateArthrosurface Recalls Uncleared Taper Post Fixation Components
FDA (Devices) · 2015-02-18
- ModerateArthrosurface Shoulder Prosthesis Components Recalled for Uncleared Marketing Status
FDA (Devices) · 2015-02-18
- ModerateArthrosurface Shoulder Prosthesis Components Recalled for Lack of US Clearance
FDA (Devices) · 2015-02-18
- ModerateArthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues
FDA (Devices) · 2015-02-18
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01