Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Recalled by Stryker Howmedica Osteonics Corp. Due to Stryker Orthopaedics has become aware of a burr,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Howmedica Osteonics Corp. directly.
Affected Products
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.
Quantity: 10, 983 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Corp. has 87 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report