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Onkos Surgical, Inc. recalls a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, C
Recalled June 4, 2025 · FDA recall Z-1879-2025 · Onkos Surgical
Hazard
Potential for breach of Tyvek seals. · FDA Class II
Units
147 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
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
Manufacturer(s)
Onkos Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →