Onkos Surgical recalls Segmental Stem components (FB-11152-03M to FB-21152-03M) due to potential Tyvek seal breaches. Affected units include specific lot numbers from 1880455 to 1880531. No remedy is stated in the recall notice.
Potential for breach of Tyvek seals.
Onkos Surgical is recalling specific Segmental Stem components used in ELEOS LIMB SALVAGE SYSTEMs because they may have Tyvek seals that could breach. This could lead to improper surgical outcomes if the seals fail during use.
The Tyvek seals in these components may breach during surgical procedures, potentially allowing contaminants to enter the surgical site. This could lead to infections or improper healing if the seals fail to maintain a sterile environment.
Surgical professionals who use the ELEOS LIMB SALVAGE SYSTEM with the recalled Segmental Stem components (model numbers FB-11152-03M through FB-21152-03M) are affected. Patients undergoing surgery with these components are at risk of potential complications due to seal breaches.
Check for model numbers FB-11152-03M through FB-21152-03M on the Segmental Stem components. Lot numbers range from 1880455 to 1880531. These components are part of the ELEOS LIMB SALVAGE SYSTEM.
Identify the model number and lot number on the Segmental Stem component to determine if it is affected.
The hazard is potential breach of Tyvek seals, which could allow contaminants to enter the surgical site during procedures.
Check for model numbers FB-11152-03M through FB-21152-03M and lot numbers from 1880455 to 1880531 on the Segmental Stem components.
The recall notice does not state any remedy or corrective action.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1882-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-1882-2025 from Onkos Surgical. 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.
