FDA Devices recall · Reported October 10, 2012
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt.
Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was…
Stryker Howmedica Osteonics Corp. recalled Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill … - a moderate-severity action.
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill … was recalled by Stryker Howmedica Osteonics Corp. in October 10, 2012. Reason: Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portio…. Check the official notice for the remedy. Verify recall #Z-2487-2012 with the FDA Devices before acting.
The recall
Stryker Howmedica Osteonics Corp. issued this moderate-severity FDA Devices recall-Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portio….
- Moderate
- severity level
- Class II
- classification
- October 10, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2487-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 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
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt.
Reason for recall
Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2487-2012 |
| Date reported | October 10, 2012 |
| Date initiated | April 2, 2012 |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Firm location | Mahwah, NJ |
| Affected scope | 10, 983 units |
| Distribution | Nationwide distribution |
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-2487-2012) 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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Nationwide recalls with similar severity or category timing
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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
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Methodology · Corrections · Archive as of August 2026