ELEOS Collar Stem Implants Recalled for Size Mislabeling in Package
Onkos Surgical recalls 23 ELEOS Collar Stem implants with incorrect sizing labels. Packages marked for 13mm implants contained 15mm diameter implants, risking surgical complications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a high-risk orthopedic surgical implant with a mislabeling hazard that could result in patient harm during surgery. No illnesses or injuries have been reported, but the risk of surgical complications from implanting the wrong-sized component is significant.
Plain-English summary
Onkos Surgical, Inc. is recalling 23 units of the ELEOS Collar Stem (Model HC-15120-03M) due to mislabeling errors in product packaging.
The affected implants were shipped in packages labeled for 13mm diameter components but actually contained 15mm diameter implants instead. This size discrepancy between the label and the actual product creates a risk that surgeons could implant the wrong-sized component during limb salvage procedures.
The recalled units were distributed nationwide in California, Kentucky, and Wisconsin. Affected healthcare facilities and surgical centers should verify inventory and contact Onkos Surgical if they have received any units matching Model Number HC-15120-03M and Serial Numbers P230274-101 through P230274-123.
Healthcare providers should not use these implants and should return them to the manufacturer. Contact Onkos Surgical for replacement or guidance on proper product identification.
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.
- Hazard
- mislabeling
- surgical-complication-risk
Distribution
Distributed nationwide across the United States.
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