Use cautionMedical device recall · FDA · Published March 5, 2021
Howmedica Osteonics Trial Cutting Guide Recall: Fracture Risk in Knee Surgery Instruments
Howmedica Osteonics recalls Trial Cutting Guides for Triathlon Total Knee Systems due to potential fracture during transport or surgery, risking injury to patients.
The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.
Take action
Contact the company
📍Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
“Howmedica Osteonics Trial Cutting Guide Recall: Fracture Risk in Knee Surgery Instruments.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63151-howmedica-osteonics-trial-cutting-guide-recall-fracture-risk-in-knee. Based on FDA recall #Z-1379-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1379-2021%22&limit=1).
The FDA announced on March 5, 2021, that Howmedica Osteonics Corp. is recalling Trial Cutting Guides for Triathlon Total Knee Systems due to fracture risks. The agency classified the Class II recall as voluntary and firm-initiated.
Specialty Triathlon TS Trial Cutting Guide Size 1 Left (I-K3834CG1L)
Specialty Triathlon TS Trial Cutting Guide Size 1 Right (I-K3834CG1R)
Specialty Triathlon TS Trial Cutting Guide Size 2 Left (I-K3834CG2L)
Specialty Triathlon TS Trial Cutting Guide Size 2 Right (I-K3834CG2R)
Specialty Triathlon TS Trial Cutting Guide Size 3 Left (I-K3834CG3L)
Specialty Triathlon TS Trial Cutting Guide Size 3 Right (I-K3834CG3R)
Specialty Triathlon TS Trial Cutting Guide Size 4 Left (I-K3834CG4L)
Specialty Triathlon TS Trial Cutting Guide Size 4 Right (I-K3834CG4R)
Specialty Triathlon TS Trial Cutting Guide Size 5 Left (I-K3834CG5L)
Specialty Triathlon TS Trial Cutting Guide Size 5 Right (I-K3834CG5R)
Specialty Triathlon TS Trial Cutting Guide Size 6 Left (I-K3834CG6L)
Specialty Triathlon TS Trial Cutting Guide Size 6 Right (I-K3834CG6R)
Specialty Triathlon TS Trial Cutting Guide Size 7 Left (I-K3834CG7L)
Specialty Triathlon TS Trial Cutting Guide Size 7 Right (I-K3834CG7R)
Specialty Triathlon TS Trial Cutting Guide Size 8 Left (I-K3834CG8L)
Specialty Triathlon TS Trial Cutting Guide Size 8 Right (I-K3834CG8R)
The hazard
According to the FDA, the posterior condyle of the Specialty Triathlon TS Trial Cutting Guides, sizes 1 through 8, may fracture at the augment cut slot. This breakage can occur during transport or when impaction occurs in surgery.
Context
GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls of similar products include Howmedica DURACON XL Angled Tibial Implants Recall (July 30, 2026), Howmedica Triathlon Baseplate Size 3 Recall (May 19, 2026), and Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026). Other recent recalls of similar products include Zimmer Off-Axis Alliance Glenoid Reamer Guide Recall (May 20, 2026) and Zimmer Off-Axis Shoulder System Recall (May 20, 2026).
How to tell if you have this one
Check for the Specialty Triathlon TS Trial Cutting Guide with catalog numbers I-K3834CG00 through I-K3834CG8R. These items were sold with specific GTIN numbers listed in the recall notice.
Brand
Howmedica Osteonics
Product
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Catalog Numbers
Look for catalog numbers I-K3834CG00 to I-K3834CG8R on the packaging or instrument itself.
Contact Manufacturer
Reach out to Howmedica Osteonics for guidance on whether your instrument is affected and next steps.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution in US to: CA,, GA, NC, NJ, NV, OK, TX, and to Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Georgia, Nevada, New Jersey, North Carolina, Oklahoma, Texas.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1379-2021 (March 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1379-2021 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.