Stryker Specialty Triathlon Knee Sizer Adjustment Housing Recalled for Fit and Marking Errors
Stryker is recalling four units of Specialty Triathlon Knee Sizer Adjustment Housings because the standard femoral stylus does not fit and the left/right markings on the right sizer are reversed.
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 source text describes a fit and labeling error without reporting any illnesses, injuries, or hospitalizations, aligning with the criteria for a moderate severity score.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling four units (two sets) of the Specialty Triathlon Left and Right A/P Sizer Adjustment Housing. These non-sterile medical devices are used for knee prosthesis implantation. The recall was initiated because the standard Triathlon Femoral Stylus does not fit into the Specialty Sizers, and the 'R' and 'L' markings on the Right Sizer are reversed.
The affected products are identified by Catalog Number I-K2401KF00 and are uniquely marked as IK2401KF0L (Left) and IK2401KF0R (Right). The specific lot codes involved are AP5W52 and AP7H19. The distribution pattern indicates that the units were shipped to one branch in New Jersey, which then distributed them to one consignee in Delaware.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and facilities should stop using these specific housings and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
Distribution
Distribution scope not specified by the agency.
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