Howmedica recalls TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM (Catalog #5532-G-413-E) due to mislabeling that may cause confusion with different sizes. This affects knee replacement implants.
“Howmedica TRIATHL: X3 TIBIAL BEARING INSERT PS #4 13MM Mislabeled Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58573-howmedica-triathl-x3-tibial-bearing-insert-ps-4-13mm-mislabeled. Based on FDA recall #Z-1654-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1654-2023%22&limit=1).
The FDA announced on April 13, 2023, that Howmedica Osteonics Corp. is recalling TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM knee replacement components due to mislabeling risks. The devices may contain incorrect catalog numbers, potentially leading to the use of wrong implants during surgery.
The recall addresses mislabeled TRIATHLON X3 TIBIAL BEARING INSERTs that may contain Catalog Number 5531-G-312-E (TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM) instead of the intended Catalog Number 5532-G-413-E, and vice versa. This labeling error creates a risk that the wrong implant size or type could be used during knee replacement procedures.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has issued 46 other recalls since July 21, 2017. Recent brand recalls include a July 30, 2026, recall of knee implant components due to oxidation risk and a May 19, 2026, recall involving confusing labeling for Triathlon Baseplate Size 4. Other recent recalls of similar products include the January 5, 2026, Encore Medical EMPOWR 3D Knee Tibial Insert packaging discrepancy recall and the June 8, 2026, Micro Therapeutics Pipeline Flex Embolization Device incorrect labeling recall.
How to tell if you have this one
Check for the Catalog Number: 5532-G-413-E on the part. This specific implant is used in knee replacements and was sold with Lot Number: 7H8RPL.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan
Recall number
Product, codes & lots
Z-1653-2023
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E; GTIN: 07613327390698 Lot Number: JH3AHJ
Z-1654-2023
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E; GTIN: 07613327338560 Lot Number: 7H8RPL
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the Catalog Number: 5532-G-413-E on the part to confirm it's the correct version.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Connecticut, Florida, Indiana, Kentucky, Montana, New Jersey, Oregon, Pennsylvania, South Carolina.
Recall timeline
FDA published this recall 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1654-2023 (April 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1654-2023 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.