Onkos Surgical recalls ELEOS Collar Stem (HC-13120-03M) due to mislabeling 15mm implants as 13mm. This could lead to improper fit during surgery. Affected units have specific serial numbers and model 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-13120-03M) because some were mislabeled as 13mm when they are actually 15mm. This could cause improper surgical fit if used without correction.
The stems were mislabeled as 13mm but are actually 15mm in diameter. This mismatch could lead to improper surgical fit, potentially causing complications during limb salvage procedures.
Surgical teams using the ELEOS Collar Stem (HC-13120-03M) for limb salvage procedures. Patients undergoing surgery with this component are most at risk if mislabeled stems are used.
Check for model number HC-13120-03M on the packaging. Affected units have serial numbers starting with P230274-1 followed by two digits (e.g., P230274-101 to P230274-123).
Look for model number HC-13120-03M and serial numbers starting with P230274-1 followed by two digits.
The stems were mislabeled as 13mm but are actually 15mm in diameter, which could cause improper surgical fit.
Check the model number and serial numbers to see if you have an affected unit. If so, contact Onkos Surgical for guidance.
The recall record does not specify a remedy, so affected users should contact Onkos Surgical directly.
We’ve drafted a message you can send Onkos Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1817-2025 — Onkos Surgical Onkos Surgical Hello, I own a Onkos Surgical that is covered by recall Z-1817-2025 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.
