Class II

Medical Device Recall: ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.

Onkos Surgical, Inc. · July 11, 2025

Reason for Recall

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

Distribution

US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.

States Affected

NATIONWIDE

Quantity Affected

554 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2425-2025

Status: ongoing

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