The Recall Desk
HighFDA (Devices)·Z-1817-2025·Announced 2025-06-04

Surgical stem implant mislabeled with 15mm diameter instead of 13mm

Onkos Surgical is recalling 23 ELEOS Collar Stem implants (model HC-13120-03M) mislabeled with 15mm diameter instead of 13mm. The affected implants were distributed in California, Kentucky, and Wisconsin.

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: FDA Class II recall of a surgical implant with critical size mismatch that presents risk of surgical complication if implanted. No illnesses or injuries reported; per the rubric, risk-of-harm products without reported injury are classified as High (3).

Plain-English summary

Onkos Surgical, Inc. is recalling 23 units of the ELEOS COLLAR STEM implant (model HC-13120-03M), a component of the Limb Salvage System with BioGrip.

The recalled implants were mislabeled and contain an incorrect diameter. Packages labeled as 13mm modular segmental stems actually contain 15mm diameter implants (model HC-15120-03M). This mismatch creates a risk that surgeons could implant an incorrectly-sized component.

The affected units were distributed nationwide in California, Kentucky, and Wisconsin. The serial numbers range from P230274-101 through P230274-123.

Healthcare providers who received these implants should verify the actual implant diameter before surgical 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.
Category
Medical Device — Surgical implant
Hazard
  • mislabeling
  • implant-size-mismatch

Distribution

Distributed nationwide across the United States.

Related recalls

Same category