FDA-Device2025-09-03Class II
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Onkos Surgical, Inc.
Hazard
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Sold states
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.
Affected count
554 units
Manufactured in
77 E Halsey Rd, Parsippany, NJ, United States
Products
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2025Don't want to check this manually?
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