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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
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