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Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Recalled September 3, 2025 · FDA recall Z-2425-2025 · Onkos Surgical
Hazard
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. · FDA Class II
Units
554 units
Sold at
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.
Description
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Product
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Manufacturer(s)
Onkos Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →