--- title: "Onkos Surgical, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Onkos Surgical, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/onkos-surgical-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Onkos Surgical, Inc. recall records **13** reported ongoing 13 records in this archive. Latest source date Jul 11, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 11, 2025 FDA device enforcement ### [ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.](https://isitonrecall.com/recall/fda-device-z-2423-2025-eleos-segmental-limb-salvage-system-eleos-bowed-canal-filling-stems-canal-filling-stem-implants/) Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. Class II Reported ongoing Distribution: 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. [Official source for ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2423-2025%22) Jul 11, 2025 FDA device enforcement ### [ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.](https://isitonrecall.com/recall/fda-device-z-2424-2025-eleos-segmental-limb-salvage-system-eleos-segmental-stem-canal-filling-straight-slotted-splined-2-3/) Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. Class II Reported ongoing Distribution: 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. [Official source for ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2424-2025%22) Jul 11, 2025 FDA device enforcement ### [ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.](https://isitonrecall.com/recall/fda-device-z-2425-2025-eleos-segmental-limb-salvage-system-eleos-stem-extension-straight-splined-slotted-canal-filling-stem/) Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. Class II Reported ongoing Distribution: 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. [Official source for ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal fill...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2425-2025%22) May 20, 2025 FDA device enforcement ### [My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device](https://isitonrecall.com/recall/fda-device-z-2042-2025-my3d-personalized-solutions-humeral-cup-model-number-c24-0223-0003-it-is-a-component-of-a-custom-con/) Required inspections were not performed on finished product prior to release and distribution. Class II Reported ongoing Distribution: US Nationwide distribution in the state of Maryland. [Official source for My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Cust...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2042-2025%22) Sep 22, 2024 FDA device enforcement ### [ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System](https://isitonrecall.com/recall/fda-device-z-1857-2025-eleos-male-female-midsection-40mm-part-number-25001040e-component-of-eleos-limb-salvage-system/) Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN. [Official source for ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1857-2025%22) Dec 22, 2023 FDA device enforcement ### [ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.](https://isitonrecall.com/recall/fda-device-z-1817-2025-eleos-collar-stem-cemented-fluted-13mm-x-120mm-model-number-hc-13120-03m-component-of-limb-salvage-s/) Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of California, Kentucky, and Wisconsin. [Official source for ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1817-2025%22) Dec 22, 2023 FDA device enforcement ### [ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.](https://isitonrecall.com/recall/fda-device-z-1818-2025-eleos-collar-stem-cemented-fluted-15mm-x-120mm-model-number-hc-15120-03m-component-of-limb-salvage-s/) Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of California, Kentucky, and Wisconsin. [Official source for ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1818-2025%22) Sep 1, 2023 FDA device enforcement ### [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-11120-03...](https://isitonrecall.com/recall/fda-device-z-1879-2025-a-segmental-stem-cemented-straight-100mm-1-each-model-numbers-cs-09100-03m-cs-10100-03m-b-segmental/) Potential for breach of Tyvek seals. Class II Reported ongoing Distribution: 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. [Official source for a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1879-2025%22) Sep 1, 2023 FDA device enforcement ### [Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM](https://isitonrecall.com/recall/fda-device-z-1880-2025-segmental-stem-cemented-bowed-152mm-1-each-model-numbers-cb-11152-03m-cb-13152-03m-cb-15152-03m-cb-1/) Potential for breach of Tyvek seals. Class II Reported ongoing Distribution: 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. [Official source for Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-151...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1880-2025%22) Sep 1, 2023 FDA device enforcement ### [Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120...](https://isitonrecall.com/recall/fda-device-z-1881-2025-segmental-stem-canal-filling-straight-120mm-1-each-model-numbers-fs-11120-03m-fs-12120-03m-fs-13120/) Potential for breach of Tyvek seals. Class II Reported ongoing Distribution: 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. [Official source for Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1881-2025%22) Sep 1, 2023 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-1882-2025-segmental-stem-canal-filling-bowed-152mm-1-each-model-numbers-fb-11152-03m-fb-12152-03m-fb-13152-03m/) Potential for breach of Tyvek seals. Class II Reported ongoing Distribution: 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. [Official source for Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1882-2025%22) Sep 1, 2023 FDA device enforcement ### [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 SEGMENT...](https://isitonrecall.com/recall/fda-device-z-1883-2025-ethos-collar-stem-cemented-fluted-100mm-1-each-model-numbers-hc-09100-03m-hc-10100-03m-hc-11120-03m/) Potential for breach of Tyvek seals. Class II Reported ongoing Distribution: 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. [Official source for Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1883-2025%22) Sep 1, 2023 FDA device enforcement ### [Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Mode...](https://isitonrecall.com/recall/fda-device-z-1884-2025-male-female-midsection-with-the-following-sizes-and-model-numbers-a-male-female-midsection-40mm-1-ea/) Potential for breach of Tyvek seals. Class II Reported ongoing Distribution: 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. [Official source for Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40m...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1884-2025%22) ## Reasons in these listed records - Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. - Required inspections were not performed on finished product prior to release and distribution. - Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur. - Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems. These examples come from this result page and are not a ranking of every recall reason. ## Checking Onkos Surgical, Inc. ### Is there a recall on onkos surgical, inc. right now? This archive contains 13 records, including 13 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Onkos Surgical, Inc.](https://isitonrecall.com/check/?q=Onkos%20Surgical%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)