Onkos Surgical recalls specific segmental stem implants due to potential breach of Tyvek seals. Affected models include CS-09100-03M, CS-10100-03M, and others with listed lot numbers. No remedy provided in recall notice.
Potential for breach of Tyvek seals.
Onkos Surgical is recalling certain segmental stem implants that may have faulty Tyvek seals. This could lead to improper surgical fixation if used in procedures. Affected products include specific model numbers and lot ranges.
The recall states there is a potential for breach of Tyvek seals. Tyvek is a type of plastic film used in medical devices to prevent contamination. If the seal breaches, it could allow improper fixation of the implant during surgery, potentially causing complications.
Surgical patients and medical professionals who use the recalled segmental stems during orthopedic procedures. Those with the listed model numbers and lot ranges are most at risk.
Check for model numbers CS-09100-03M, CS-10100-03M, CS-11120-03M, CS-13120-03M, or CS-15120-03M. Also look for lot numbers starting with 1880308 through 1880454. These items are part of the ELEOS LIMB SALVAGE SYSTEM.
Identify the model number and lot number on the device to see if it matches the recalled items.
The recall states there is a potential for breach of Tyvek seals, which could lead to improper surgical fixation if used in procedures.
The recall notice does not provide a remedy. You should check the product details to see if it matches the recalled items and contact Onkos Surgical for further instructions.
Yes, the affected lot numbers range from 1880308 to 1880454 for the listed model 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-1879-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-1879-2025 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.
