Howmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk
Howmedica Osteonics Corp. is recalling 605 Triathlon Universal Baseplate Finishing 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 use of the product 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 605 units of the TS Universal Baseplate Finishing Tray, Triathlon (Catalog Number: 6543-6-506). The recall involves trays distributed by sale or loan, including 158 trays distributed outside the United States. All lot numbers used prior to the correction date of May 8, 2026, are impacted.
The recall is due to reprocessing instructions that specify a 30-minute sterilization dry time for trays sterilized in blue wrap. When blue wrap is used, this dry time may lead to a small amount of residual moisture remaining after sterilization.
The source text does not report any illnesses, injuries, or deaths associated with this product. Users should contact Howmedica Osteonics Corp. for further instructions regarding the recall.
The recalled product
- Product
- TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- Affected units
- 605
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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