Onkos Surgical recalls ELEOS Collar Stem (HC-15120-03M) due to mislabeling as 13mm when it's 15mm. This could lead to improper implant fitting during surgery. Affected units have specific model and serial numbers.
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Onkos Surgical is recalling ELEOS Collar Stems (model HC-15120-03M) because they were mislabeled as 13mm when they're actually 15mm. This mislabeling could cause improper implant fitting during surgery, potentially leading to complications.
The stems were labeled as 13mm but are actually 15mm in diameter. This size mismatch could lead to improper fitting during surgery, potentially causing complications like improper joint alignment or instability.
Patients undergoing limb salvage surgery who received this specific ELEOS Collar Stem model. Surgeons and surgical teams using the product are most at risk of improper implant fitting.
Check for model number HC-15120-03M on the product. Serial numbers start with P230274-1 and go up to P230274-123. The product is part of a limb salvage system with BioGrip.
Review the model number and serial numbers to confirm if your ELEOS Collar Stem is affected.
The stems were mislabeled as 13mm when they are actually 15mm in diameter, which could lead to improper implant fitting during surgery.
Check the model number and serial numbers to see if your product is affected. If it is, contact Onkos Surgical for further instructions.
The recall addresses a potential risk of improper implant fitting during surgery, but no specific injuries have been reported. The hazard is low risk as it relates to surgical procedures.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1818-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-1818-2025 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.
