--- title: "Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-0... — FDA record Z-1882-2025 | Is It on Recall" description: "Potential for breach of Tyvek seals." url: 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/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152... — FDA record Z-1882-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Sep 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. 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/). ## What the record says - **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 - **Reason**: Potential for breach of Tyvek seals. - **Classification**: Class II - **Recalling firm**: Onkos Surgical, Inc. - **Quantity**: 77 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1882-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1882-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | a. Model Number: FB-11152-03M; UDI-DI: B278FB1115203M0; Lot Numbers: 1880455, 1880456, 1880457, 1880458, 1880459, 1880460, 1880461, 1880462, 1880463. b. Model Number: FB-12152-03M; UDI-DI: B278FB1215203M0; Lot Numbers: 1880464, 1880465, 1880466, 1880467, 1880468, 1880469. c. Model Number: FB-13152-03M; UDI-DI: B278FB1315203M0; Lot Numbers: 1880470, 1880471, 1880472, 1880473. d. Model Number: FB-14152-03M; UDI-DI: B278FB1415203M0; Lot Numbers: 1880474, 1880475, 1880476. e. Model Number: FB-15152-03M; UDI-DI: B278FB1515203M0; Lot Numbers: 1880477, 1880478, 1880479. f. Model Number: FB-16152-03M; UDI-DI: B278FB1615203M0; Lot Numbers: 1880480, 1880481, 1880482, 1880483, 1880484, 1880485, 1880486, 1880487, 1880488. g. Model Number: FB-17152-03M; UDI-DI: B278FB1715203M0; Lot Numbers: 1880489, 1880490, 1880491, 1880492, 1880493, 1880494, 1880495, 1880496, 1880497. h. Model Number: FB-18152-03M; UDI-DI: B278FB1815203M0; Lot Numbers: 1880498, 1880499, 1880500, 1880501, 1880502, 1880503, 1880504, 1880505. i. Model Number: FB-19152-03M; UDI-DI: B278FB1915203M0; Lot Numbers: 1880506, 1880507, 1880508, 1880509, 1880510, 1880511. j. Model Number: FB-20152-03M; UDI-DI: B278FB2015203M0; Lot Numbers: 1880512, 1880513, 1880514, 1880515, 1880516, 1880517, 1880518. k. Model Number: FB-21152-03M; UDI-DI: B278FB2115203M0; Lot Numbers: 1880519, 1880520, 1880521, 1880522, 1880523, 1880524, 1880525, 1880526, 1880527, 1880528, 1880529, 1880530, 1880531. | Match all identifying details in the current notice. A brand name alone is not enough. ## 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. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Arizona](https://isitonrecall.com/state/arizona/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Texas](https://isitonrecall.com/state/texas/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) ## Dates in the source - **Report date**: Jun 4, 2025 - **Recall initiation date**: Sep 1, 2023 - **Center classification date**: May 29, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1882-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Onkos Surgical, Inc. records](https://isitonrecall.com/brand/onkos-surgical-inc/)