Howmedica Triathlon Revision Knee Implants Recalled for Sizing Errors
Howmedica Osteonics Corp. is recalling 77 Triathlon Revision Knee implants because customers may receive the incorrect size from what is labeled on the box.
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. The hazard involves a labeling error resulting in the potential for incorrect implant sizing, which is a significant quality issue but does not explicitly report injuries or deaths in the provided text, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Howmedica Osteonics Corp. is recalling 77 units of the Triathlon Revision Knee system, specifically Catalog #5545-A-301 and Catalog #5546-A-601. These are sterile, single-use medical devices intended for use in revision total knee arthroplasty to alleviate pain and restore function.
The recall was initiated because customers may receive the incorrect size implant from what is labeled on the box. The affected lots include ER9WA1A, ER9WA1D, and ER9WA1E for Catalog #5545-A-301, and ER9MA5A for Catalog #5546-A-601.
The products were distributed nationwide to the states of AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. Healthcare providers and patients should contact Howmedica Osteonics Corp. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 77
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 (5)
- Catalog #5545-A-301
- lot code ER9WA1A
- ER9WA1D
- ER9WA1E Catalog #5546-A-601
- lot code ER9MA5A
Distribution
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