ELEOS Collar Stem Cemented Fluted Implant Size Mislabeling Recall
Onkos Surgical is recalling 23 units of ELEOS Collar Stem implants (Model HC-13120-03M) because packages labeled as 13mm contained 15mm diameter implants instead, creating a risk of implant mismatch during 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 involving a surgical implant with a size mismatch that could result in improper surgical placement and patient harm. The mislabeling of a critical surgical component presents a risk of significant injury during or after implantation, meeting the Severe threshold.
Plain-English summary
Onkos Surgical, Inc. is recalling 23 units of ELEOS Collar Stem, Cemented, Fluted implants (Model Number HC-13120-03M) distributed nationwide in California, Kentucky, and Wisconsin. The implants were mislabeled on the package—units labeled as 13mm diameter cemented stems actually contained 15mm diameter implants.
The mislabeling creates a risk that the wrong size implant could be selected and used during limb salvage surgical procedures. This component is part of the Limb Salvage System with BioGrip. The affected units have Serial Numbers P230274-1XX (where XX represents sequential numbers 101-123).
Patients and healthcare providers who have received or implanted these devices should contact Onkos Surgical to confirm whether the correct implant size was used and to discuss appropriate follow-up. Healthcare facilities should verify the actual implant size in their inventory against the labeling before use.
The recalled product
- Product
- ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
- Manufacturer
- Onkos Surgical, Inc.
- Hazard
- mislabeling
- size-mismatch
- surgical-implant-defect
Distribution
Distributed nationwide across the United States.
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