FDA Devices recall · Reported February 18, 2015
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Arthrosurface, Inc. recalled Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-00… - a moderate-severity action.
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-00… was recalled by Arthrosurface, Inc. in February 18, 2015. Reason: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.. Check the official notice for the remedy. Verify recall #Z-1114-2015 with the FDA Devices before acting.
The recall
Arthrosurface, Inc. issued this moderate-severity FDA Devices recall-Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications..
- Moderate
- severity level
- 187 units
- affected scope
- Class II
- classification
- February 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1114-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1114-2015) was formally reported on February 18, 2015, with the manufacturer initiating the action on November 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Arthrosurface, Inc. is listed as the recalling firm, operating out of Franklin, MA. Federal records list the affected scope as 187.
The documented reason for this recall is: Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1114-2015 |
| Date reported | February 18, 2015 |
| Date initiated | November 24, 2014 |
| Recalling firm | Arthrosurface, Inc. |
| Firm location | Franklin, MA |
| Affected scope | 187 |
| Distribution | Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1114-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026