Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker… — Class II medical device recall Z-2487-2012
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2012-10-10, distributed nationwide. Stryker Orthopaedics has become aware of a burr, or a metal shaving, observed in the internal threaded portion
| Recall number | Z-2487-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2012-04-02 |
| Classified | 2012-09-28 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2013-06-13 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material |
| Model numbers | 6278-1-019 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2487-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.