ELEOS Collar Stem 15mm mistakenly labeled as 13mm modular stem
Onkos Surgical is recalling ELEOS Collar Stem components (Model HC-15120-03M) that were packaged and labeled as 13mm modular segmental stems when they are actually 15mm in diameter. This mislabeling could result in implantation of an incorrectly-sized component during limb salvage surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of an orthopedic implant with critical patient safety implications. A mislabeled surgical implant of incorrect size could result in improper surgical placement, structural failure, or patient harm during limb salvage procedures, meeting the criterion for Severe severity.
Plain-English summary
Onkos Surgical, Inc. is recalling 23 units of the ELEOS Collar Stem, Cemented, Fluted, 15mm x 120mm (Model Number HC-15120-03M), a component of the Limb Salvage System with BioGrip. The affected units were distributed nationwide to hospitals and surgical centers in California, Kentucky, and Wisconsin.
The recalled implants were mislabeled as 13mm modular segmental stems (Model HC-13120-03M) when they are actually 15mm in diameter. Packages indicated the contained stem was 13mm cemented in size, but the actual implant was 15mm cemented. This mislabeling could lead a surgeon to implant an implant of incorrect size during limb salvage surgery.
Affected units have Serial Numbers P230274-101 through P230274-123. Patients who received these implants or healthcare facilities with inventory should contact Onkos Surgical, Inc. immediately to identify whether they have affected units and determine the appropriate next steps.
The recalled product
- Product
- ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
- Manufacturer
- Onkos Surgical, Inc.
- Affected units
- 23
Distribution
Part of a larger recall action
This product is one of 2 recalled by Onkos Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Onkos Surgical, Inc.
See all →- HighLimb salvage canal filling stems recalled after unidentified substance found on devices
FDA (Devices) · 2025-09-03
- HighLimb salvage stem extensions recalled after unidentified substance found on devices
FDA (Devices) · 2025-09-03
- HighCanal filling stems recalled after unidentified substance found during retrospective evaluation
FDA (Devices) · 2025-09-03
- ModerateMy3D Personalized Solutions Humeral Cup lacks required inspections
FDA (Devices) · 2025-07-09
- ModerateMale-Female Midsection components from ELEOS Segmental Limb Salvage System
FDA (Devices) · 2025-06-04
Same hazard · mislabeling
See all →- ModerateOrthofix MINIRAIL External Fixation Devices Incorrectly Labeled
FDA (Devices) · 2026-07-22
- ModerateWise Onion Rings recalled for undeclared food color additives
FDA (Food) · 2026-07-15
- HighBakr Brown Butter Chocolate Chunk Cookie Dough Recalled for Undeclared Soy
FDA (Food) · 2026-07-15
- HighStapes prosthesis pistons carry an incorrect functional length on labeling
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03