Onkos Surgical recalls Male-Female Midsection implants with specific sizes and model numbers due to potential breach of Tyvek seals. Affected units include 40mm to 140mm sizes with model numbers 25001040E through 25001140E.
Potential for breach of Tyvek seals.
Onkos Surgical is recalling Male-Female Midsection implants with specific sizes (40mm to 140mm) and model numbers 25001040E through 25001140E. The recall is due to a potential breach of Tyvek seals, which could lead to complications during medical procedures.
The implants may have Tyvek seals that breach during use, potentially allowing contaminants to enter the surgical site. This could lead to infections or other complications during the procedure.
Patients who have received these specific Male-Female Midsection implants as part of the ELEOS SEGMENTAL LIMB SALVAGE SYSTEM are affected. Surgeons and medical staff using these implants during procedures are at the highest risk.
Check if your implant has a model number starting with 25001040E to 25001140E and a size between 40mm and 140mm. Lot numbers listed in the recall include sequences starting with 1880172 through 1880258.
Identify if your implant matches the model numbers 25001040E through 25001140E and sizes 40mm to 140mm.
The implants may have Tyvek seals that breach during use, potentially allowing contaminants to enter the surgical site.
Check if your implant has a model number starting with 25001040E to 25001140E and a size between 40mm and 140mm. Lot numbers listed in the recall include sequences starting with 1880172 through 1880258.
No action is required if your implant does not match the model numbers or sizes listed in the recall.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1884-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-1884-2025 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.
