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Onkos Surgical, Inc. recalls Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03
Recalled June 4, 2025 · FDA recall Z-1883-2025 · Onkos Surgical
Hazard
Potential for breach of Tyvek seals. · FDA Class II
Units
233 units
Sold at
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.
Description
Potential for breach of Tyvek seals.
Product
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
Manufacturer(s)
Onkos Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →