Howmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk
Howmedica Osteonics Corp. is recalling 359 Triathlon Hinge Femoral Prep Trays because reprocessing instructions may leave residual moisture after sterilization.
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 Class II because the reprocessing instructions may leave residual moisture after sterilization, which may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Howmedica Osteonics Corp. is recalling 359 units of the Triathlon Hinge Femoral Prep Tray, Catalog Number 6543-6-514. The recall is due to reprocessing instructions that specify a 30-minute sterilization dry time for trays sterilized in blue wrap. This dry time may lead to a small amount of residual moisture remaining after sterilization.
The affected trays were distributed by sale or loan, with 158 trays distributed outside the United States. All lot numbers used prior to the correction date of May 8, 2026, are impacted. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 359
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)
- 2026 are impacted.
Distribution
Distribution scope not specified by the agency.
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