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Onkos Surgical, Inc. recalls Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03
Recalled June 4, 2025 · FDA recall Z-1882-2025 · Onkos Surgical
Hazard
Potential for breach of Tyvek seals. · FDA Class II
Units
77 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
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Manufacturer(s)
Onkos Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →