Exactech recalls Truliant Splined Stem Extension implants with a labeling error that shows 17mm x 80mm instead of 18mm x 120mm. This affects cemented total knee prosthesis systems.
These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
“Exactech Truliant Splined Stem Extension Labeling Error Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65950-exactech-truliant-splined-stem-extension-labeling-error-recall. Based on FDA recall #Z-1364-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1364-2020%22&limit=1).
The FDA announced on Jan. 27, 2020, that Exactech, Inc. is recalling Truliant Splined Stem Extension devices due to a labeling error that misidentifies the implant size. The agency issued recall number Z-1364-2020 for the Class II voluntary recall.
How to tell if you have it
Brand: Exactech
Product: Truliant Splined Stem Extension, 18mm x 120mm
Catalog no: 02-012-64-1812
Serial numbers: 6366405, 6367075, 6367076
Quantity: 4 units
The hazard
The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the actual implant size is 18mm x 120mm. The devices are used in a cemented total knee prosthesis system.
Context
GovInfoNow's records show Exactech, Inc. has had 34 other recalls since June 23, 2017. Recent brand recalls include an Equinoxe Ergo Modular Impactor Handle recall on Feb. 3, 2026, for a missing cross-pin hazard and an Equinoxe Ergo Adjustable Angle rTSA Reamer 46mm recall on Sept. 5, 2025, for incomplete design updates. Other recent recalls of similar products include Micro Therapeutics Pipeline Flex Embolization Device Labeling Error (June 8, 2026) and EMPOWR 3D KNEE Implants Have Incorrect Labeling (Jan. 15, 2026).
How to tell if you have this one
Check the label on the Truliant Splined Stem Extension for the size listed as 17mm x 80mm instead of 18mm x 120mm. The product is used in cemented total knee prosthesis systems and has specific serial numbers: 6366405, 6367075, 6367076.
Brand
Exactech
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Label
Verify the label shows 17mm x 80mm instead of 18mm x 120mm.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, CO and FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Colorado, Florida.
Recall timeline
FDA published this recall 37 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-1364-2020 (January 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1364-2020 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.