Howmedica Triathlon Tritanium Tibial Component Size 6 Recall: Label Mismatch
Howmedica recalls Triathlon Tritanium Tibial Components (Size 6) due to potential mismatch between product size and package labeling. Affected units include specific catalog numbers and lots.
Lower-risk recall
Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
Contact the company
What happened, in plain English
Howmedica is recalling Triathlon Tritanium Tibial Components (Size 6) because the actual product size may not match what's labeled on the package. This mismatch could lead to incorrect use in medical procedures. Read more at govinfonow.com/recall/60866-howmedica-triathlon-tritanium-tibial-component-size-6-recall-label-mismatch.
Source Summary by GovInfoNow · govinfonow.com/recall/60866-howmedica-triathlon-tritanium-tibial-component-size-6-recall-label-mismatch · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1237-2022
Cite this page
“Howmedica Triathlon Tritanium Tibial Component Size 6 Recall: Label Mismatch.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60866-howmedica-triathlon-tritanium-tibial-component-size-6-recall-label-mismatch. Based on FDA recall #Z-1237-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1237-2022%22&limit=1).
Why it’s dangerous
The product size inside the package may differ from what's labeled on the packaging. This mismatch could cause incorrect component use during surgery, potentially leading to improper joint replacement procedures.
Who’s affected
Patients who received the Triathlon Tritanium Tibial Component (Size 6) with catalog number 5536-B-600 or lot numbers 07613327041514 and CTD69463 are affected. Surgeons and medical teams using these components for joint replacements are most at risk.
How to tell if you have this one
Check for the Triathlon Tritanium Tibial Component (Size 6) with catalog number 5536-B-600 or lot numbers 07613327041514 and CTD69463. The product may also be labeled as Size 5 with catalog number 5536-B-500.
- Brand
Howmedica- Category
Medical device
What to do — step by step
Check Product Labeling
Verify the product size and catalog number on the package against the listed numbers: Size 6 with catalog number 5536-B-600 or Size 5 with catalog number 5536-B-500.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
FDA distribution: “Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, and WV. The countries of UK and Poland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Idaho, Indiana, Kansas, Michigan, Nevada, Pennsylvania, Tennessee, Washington, West Virginia.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1237-2022 (March 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1237-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.