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.
Howmedica Osteonics is recalling Trial Cutting Guides for certain knee replacement systems because the posterior condyle can fracture during shipping or surgery. This could lead to complications for patients during knee surgery.
The posterior condyle of the Trial Cutting Guide can fracture during shipping or when the instrument is used in surgery. This fracture could cause injury to the patient during the procedure or damage the surgical instrument.
Patients undergoing knee replacement surgery using the recalled Trial Cutting Guides are at risk. Surgeons and medical staff using these specific instruments during procedures may need to take extra care.
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.
Look for catalog numbers I-K3834CG00 to I-K3834CG8R on the packaging or instrument itself.
Reach out to Howmedica Osteonics for guidance on whether your instrument is affected and next steps.
The recall affects Specialty Triathlon TS Trial Cutting Guides for Triathlon Total Knee System, Triathlon PKR System, and Restoris MCK Knee System, sizes 1 through 8 (left and right).
Check the catalog numbers on the packaging: I-K3834CG00 to I-K3834CG8R. Also, verify the GTIN numbers listed in the recall notice.
Contact Howmedica Osteonics directly to determine if your instrument is affected and to get instructions on next steps.
We’ve drafted a message you can send Howmedica Osteonics to request your refund or repair — edit it as you like.
Subject: Recall Z-1379-2021 — Howmedica Osteonics Howmedica Osteonics Hello, I own a Howmedica Osteonics that is covered by recall Z-1379-2021 from Howmedica Osteonics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
