Medical device recalls Moderate risk

Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

Recall date
July 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2423-2025
FDA classification
Class II
Brand / firm
Onkos Surgical, Inc.
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

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