Stryker Orthopaedics Recalls Cone Body Trials Due to Metal Shavings
Stryker Howmedica Osteonics Corp. is recalling 10,983 Restoration Modular Cone Body Trials because metal shavings were found in the internal threaded portion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a manufacturing defect (metal shavings) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 10,983 units of Stryker Orthopaedics Restoration Modular Cone Body Trials. These medical devices are used by surgeons to simulate the fit of proposed implants during orthopedic procedures. The recall covers various catalog numbers and sizes, including standard and extended cone trials.
The recall was initiated after Stryker Orthopaedics became aware of a burr, or metal shaving, observed in the internal threaded portion of the Cone Body Trial. The typical size of the observed shavings was 1-2 mm in length and 0.037 mm squared in cross section. The affected units were distributed nationwide.
Healthcare providers and facilities that have received these devices should stop using them and contact Stryker Howmedica Osteonics Corp. for instructions on how to return or dispose of the affected units. Patients who have already had surgery using these trials should consult their healthcare provider if they have concerns.
The recalled product
- 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…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
Distribution
Distributed nationwide across the United States.
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