Onkos Surgical recalls ELEOS MALE-FEMALE MIDSECTION 40MM (Part 25001040E) due to potential assembly issues during surgery. Affected units have specific lot numbers and UDI-DI codes.
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Onkos Surgical is recalling a specific surgical midsection component because it may cause assembly problems during surgery. This could lead to complications if the part doesn't fit correctly with the femur section.
The midsection part may not assemble properly with the femur section during surgery, potentially causing complications. This could happen if the external taper doesn't align correctly with the internal taper.
Surgical teams using the ELEOS Limb Salvage System with the recalled midsection part. Surgeons and surgical staff are most at risk during assembly.
Check for part number 25001040E on the ELEOS MALE-FEMALE MIDSECTION 40MM. Affected units have lot numbers 1989873 or 1989874 and UDI-DI code B27825001040E0.
Look for part number 25001040E, lot numbers 1989873 or 1989874, and UDI-DI code B27825001040E0 on the item.
Yes, this part is a component of the ELEOS Limb Salvage System used during surgery.
The recall record does not specify a remedy, so check with Onkos Surgical for guidance.
Look for part number 25001040E, lot numbers 1989873 or 1989874, and UDI-DI code B27825001040E0.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1857-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-1857-2025 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.