a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH recallZ-1879-2025 · Onkos Surgical, Inc. · initiated Sep 1, 2023
Class II Open, Classified All recalls posted in May 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Onkos Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for breach of Tyvek seals.
FDA root cause category: Packaging change control
What the company is doing
Onkos Surgical began notifying consignees on about 09/01/2023 via email. Consignees were instructed to complete and return the response form providing the affected lot numbers being returned, coordinate the return of affected units, and to note that when placing these parts into totes, always place them flat.
Recall details
- Recall number
- Z-1879-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Sep 1, 2023
- Posted by the FDA
- May 29, 2025
- Recalling firm
- Onkos Surgical, Inc.
- Quantity
- 147 units
- Product code
- KRO
- FDA submissions
- K161520
- 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.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
a. Model Number: CS-09100-03M; UDI-DI: B278CS0910003M0; Lot Numbers: 1880308, 1880309, 1880310, 1880311, 1880312, 1880313, 1880314, 1880315, 1880316, 1880317, 1880318, 1880319, 1880320, 1880321, 1880322, 1880323, 1880324, 1880325, 1880326, 1880327, 1880328, 1880329, 1880330, 1880331, 1880332, 1880333. Model Number: CS-10100-03M. UDI-DI: B278CS1010003M0. Lot Numbers: 1880334, 1880335, 1880336, 1880337, 1880338, 1880339, 1880340, 1880341, 1880342, 1880343, 1880344, 1880345. b. Model Number: CS-11120-03M; UDI-DI: B278CS1112003M0; Lot Numbers: 1880346, 1880347, 1880348, 1880349, 1880350, 1880351, 1880352, 1880353, 1880354, 1880355, 1880356, 1880357, 1880358, 1880359, 1880360, 1880361, 1880362, 1880363, 1880364, 1880365, 1880366, 1880367, 1880368, 1880369, 1880370, 1880371, 1880372, 1880373, 1880374, 1880375, 1880376. Model Number: CS-13120-03M; UDI-DI: B278CS1312003M0; Lot Numbers: 1880377, 1880378, 1880379, 1880380, 1880381, 1880382, 1880383, 1880384, 1880385, 1880386, 1880387, 1880388, 1880389, 1880390, 1880391, 1880392, 1880393, 1880394, 1880395, 1880396, 1880397, 1880398, 1880399, 1880400, 1880401, 1880402, 1880403, 1880404, 1880405, 1880406, 1880407, 1880408, 1880409. Model Number: CS-15120-03M; UDI-DI: B278CS1512003M0; Lot Numbers: 1880410, 1880411, 1880412, 1880413, 1880414, 1880415, 1880416, 1880417, 1880418, 1880419, 1880420, 1880421, 1880422, 1880423, 1880424, 1880425. Model Number: CS-17120-03M; UDI-DI: B278CS1712003M0; Lot Numbers: 1880426, 1880427, 1880428, 1880429, 1880430, 1880431, 1880432, 1880433, 1880434, 1880435, 1880436, 1880437, 1880438, 1880439, 1880440, 1880441, 1880442, 1880443, 1880444, 1880445, 1880446, 1880447, 1880448, 1880449, 1880450, 1880451, 1880452, 1880453, 1880454.
Other devices under the same FDA submission
157 devices cleared under K161520 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- ELEOS™ 25000007EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 death86 reports
- ELEOS™ 25002100EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 deaths83 reports
- ELEOS™ 25000009EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 deaths73 reports
- ELEOS™ 25001040EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths68 reports
- ELEOS™ 25001210EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented43 reports
- ELEOS™ 25001212EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented33 reports
- ELEOS™ 25001220EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented30 reports
- ELEOS™ 25002113EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death29 reports
- ELEOS™ 25001216EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death26 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96782).
- Z-1881-2025 · Open, ClassifiedSegmental 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-18120-03…
- Z-1882-2025 · Open, ClassifiedSegmental 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, F…
- Z-1884-2025 · Open, ClassifiedMale-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; Model…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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