Onkos Surgical recalls certain Segmental Stem implants due to potential breach of Tyvek seals. Affected models include CB-11152-03M through CB-17152-03M with specific lot numbers. No remedy is stated in the recall notice.
Potential for breach of Tyvek seals.
Onkos Surgical is recalling specific segmental stem implants used in limb salvage surgery. The recall is due to a potential breach of Tyvek seals, which could lead to complications during surgical procedures.
The segmental stems have a potential risk of Tyvek seals being breached during surgery. This could compromise the surgical site and lead to complications such as infection or improper healing.
Orthopedic surgeons and medical facilities that use the recalled segmental stems for limb salvage procedures. Patients who have received these implants are not directly affected by the recall.
Check if your implant has model numbers CB-11152-03M, CB-13152-03M, CB-15152-03M, or CB-17152-03M with specific lot numbers listed in the recall notice.
Identify the model number and lot numbers on your implant to determine if it is affected by this recall.
No, patients who have received the recalled implants are not directly affected by this recall. The recall applies to medical facilities using the implants.
The hazard is a potential breach of Tyvek seals during surgery, which could lead to complications such as infection or improper healing.
The recall notice does not state any remedy or action required for the affected implants.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1880-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-1880-2025 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.
