FDA-Device2025-06-04Class II
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Onkos Surgical, Inc.
Hazard
Potential for breach of Tyvek seals.
Sold states
Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.
Affected count
233 units
Manufactured in
77 E Halsey Rd, N/A, Parsippany, NJ, United States
Products
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1883-2025Don't want to check this manually?
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