Onkos Surgical recalls Ethos Collar Stem (models HC-09100-03M to HC-17120-03M) due to potential breach of Tyvek seals. Affected units include specific lot numbers from 1880652 to 1880884.
Potential for breach of Tyvek seals.
Onkos Surgical is recalling Ethos Collar Stem components (models HC-09100-03M to HC-17120-03M) because they may breach Tyvek seals. This could lead to improper surgical site sealing, potentially causing infection or complications during procedures.
The Ethos Collar Stem components may breach Tyvek seals during use, which are critical for maintaining a sterile surgical environment. This breach could allow contaminants to enter the surgical site, increasing the risk of infection or complications.
Surgical patients and healthcare providers using the Ethos Collar Stem components in ELEOS SEGMENTAL LIMB SALVAGE SYSTEM procedures. The risk is primarily for those with the specific model numbers and lot ranges listed.
Check if your Ethos Collar Stem has model numbers HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, or HC-17120-03M. The lot numbers range from 1880652 to 1880884.
Identify the model number on your Ethos Collar Stem to see if it matches HC-09100-03M through HC-17120-03M.
Confirm the lot number is within the range 1880652 to 1880884 for affected units.
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 HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, or HC-17120-03M, and if the lot number is between 1880652 and 1880884.
The recall does not specify an immediate stop-use requirement; affected units should be checked for model and lot numbers.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1883-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-1883-2025 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.
