Onkos Surgical recalls Segmental Stem components (FS-11120-03M to FS-21120-03M) due to potential Tyvek seal breaches. Affected units include specific lot numbers for each model. No remedy provided in recall notice.
Potential for breach of Tyvek seals.
Onkos Surgical is recalling certain 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 seal fails during use. Consumers should check their model numbers and lot numbers to see if they are affected.
The Segmental Stem components may have Tyvek seals that can breach during surgical procedures. This breach could allow contaminants to enter the surgical site, potentially leading to infection or improper healing of the limb.
Medical professionals using the ELEOS LIMB SALVAGE SYSTEM with the recalled Segmental Stem components are most at risk. Patients who have received these components during surgery may also be affected.
Check if your Segmental Stem is labeled with model numbers FS-11120-03M through FS-21120-03M. Look for specific lot numbers listed for each model in the recall notice.
Identify your Segmental Stem model number from the product label to see if it matches FS-11120-03M through FS-21120-03M.
The hazard is potential breach of Tyvek seals, which could allow contaminants to enter the surgical site during procedures.
Check if your model number is FS-11120-03M through FS-21120-03M and if your lot number matches the specific list provided for that model.
The recall notice does not provide a remedy; consumers are advised to check if their product is affected and contact the manufacturer if needed.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1881-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-1881-2025 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.
