Stryker Triathlon X3 Tibial Bearing Insert Recall Due to Labeling Error
Stryker is recalling 10 units of Triathlon X3 Tibial Bearing Inserts because one unit was found in a pack labeled for a different model.
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, but the source text describes a labeling error without reporting any injuries, illnesses, or hospitalizations. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 10 units of the Triathlon X3 Tibial Bearing Insert - CR (Catalog number 5530-G-209, Lot Code LEF064). This component is part of the Triathlon Total Knee System and is used for fixation to tibial baseplates via a locking wire mechanism.
The recall was initiated after a report identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was found in a package labeled as a CR insert (5530-G-209). This labeling discrepancy creates a risk of using the wrong component during surgical procedures.
The affected units were distributed to facilities in Ohio, South Carolina, Rhode Island, and West Virginia. Healthcare providers should verify the catalog number and lot code of their inventory to ensure they are not using the mislabeled product.
The recalled product
- Product
- Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog number 5530-G-209 Lot Code LEF064
Distribution
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