Severity
Moderate
ModerateClass IITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-2487-2012) was formally reported on October 10, 2012, with the manufacturer initiating the action on April 2, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Howmedica Osteonics Corp. is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 10, 983 units.
The documented reason for this recall is: 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 i… Distribution data in the federal record shows the product reached: Nationwide distribution. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
10, 983 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Howmedica Osteonics Corp.. Units affected: 10, 983 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2012. Severity: Moderate. Recall number: Z-2487-2012.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2487-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 10, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.