Exact FDA event identifier

Event 96782

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 01, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Onkos Surgical, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

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

Z-1879-2025

Recall number: Z-1879-2025
Initiated: September 01, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Onkos Surgical, Inc.
Quantity: 147 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for breach of Tyvek seals.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for breach of Tyvek seals.

Code information

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.

Distribution pattern

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.

device · product 2 of 6

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

Z-1880-2025

Recall number: Z-1880-2025
Initiated: September 01, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Onkos Surgical, Inc.
Quantity: 49 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for breach of Tyvek seals.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for breach of Tyvek seals.

Code information

a. Model Number: CB-11152-03M; UDI-DI: B278CB1115203M0; Lot Numbers: 1880259, 1880260, 1880261, 1880262, 1880263, 1880264, 1880265, 1880266, 1880267, 1880268, 1880269, 1880270, 1880271, 1880272, 1880273, 1880274. b. Model Number: CB-13152-03M; UDI-DI: B278CB1315203M0; Lot Numbers: 1880275, 1880276, 1880277, 1880278, 1880279, 1880280, 1880281, 1880282, 1880283, 1880284. c. Model Number: CB-15152-03M; UDI-DI: B278CB1515203M0; Lot Numbers: 1880285, 1880286, 1880287, 1880288, 1880289, 1880290, 1880291, 1880292, 1880293, 1880294, 1880295, 1880296. d. Model Number: CB-17152-03M; UDI-DI: B278CB1715203M0; Lot Numbers: 1880297, 1880298, 1880299, 1880300, 1880301, 1880302, 1880303, 1880304, 1880305, 1880306, 1880307.

Distribution pattern

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.

device · product 3 of 6

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-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM

Z-1881-2025

Recall number: Z-1881-2025
Initiated: September 01, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Onkos Surgical, Inc.
Quantity: 120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for breach of Tyvek seals.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for breach of Tyvek seals.

Code information

a. Model Number: FS-11120-03M; UDI-DI: B278FS1112003M0; Lot Numbers: 1880532, 1880533, 1880534, 1880535, 1880536, 1880537, 1880538, 1880539, 1880540, 1880541, 1880542, 1880543. b. Model Number: FS-12120-03M; UDI-DI: B278FS1212003M0; Lot Numbers: 1880544, 1880545, 1880546, 1880547, 1880548, 1880549, 1880550, 1880551, 1880552, 1880553. c. Model Number: FS-13120-03M; UDI-DI: B278FS1312003M0; Lot Numbers: 1880554, 1880555, 1880556, 1880557, 1880558, 1880559, 1880560, 1880561, 1880562, 1880563. d. Model Number: FS-14120-03M; UDI-DI: B278FS1412003M0; Lot Numbers: 1880564, 1880565, 1880566, 1880567, 1880568, 1880569, 1880570, 1880571, 1880572, 1880573, 1880574. e. Model Number: FS-15120-03M; UDI-DI: B278FS1512003M0; Lot Numbers: 1880575, 1880576, 1880577, 1880578, 1880579, 1880580, 1880581, 1880582, 1880583, 1880584, 1880585, 1880586, 1880587. f. Model Number: FS-16120-03M; UDI-DI: B278FS1612003M0; Lot Numbers: 1880588, 1880589, 1880590, 1880591, 1880592, 1880593, 1880594, 1880595, 1880596, 1880597, 1880598. g. Model Number: FS-17120-03M; UDI-DI: B278FS1712003M0; Lot Numbers: 1880599, 1880600, 1880601, 1880602, 1880603, 1880604, 1880605, 1880606, 1880607, 1880608, 1880609, 1880610, 1880611. h. Model Number: FS-18120-03M; UDI-DI: B278FS1812003M0; Lot Numbers: 1880612, 1880613, 1880614, 1880615, 1880616, 1880617, 1880618, 1880619, 1880620, 1880621, 1880622, 1880623. i. Model Number: FS-19120-03M; UDI-DI: B278FS1912003M0; Lot Numbers: 1880624, 1880625, 1880626, 1880627, 1880628, 1880629, 1880630, 1880631, 1880632. j. Model Number: FS-20120-03M; UDI-DI: B278FS2012003M0; Lot Numbers: 1880633, 1880634, 1880635, 1880636, 1880637, 1880638, 1880639. k. Model Number: FS-21120-03M; UDI-DI: B278FS2112003M0; Lot Numbers: 1880640, 1880641, 1880642, 1880643, 1880644, 1880645, 1880646, 1880647, 1880648, 1880649, 1880650, 1880651.

Distribution pattern

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.

device · product 4 of 6

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

Z-1882-2025

Recall number: Z-1882-2025
Initiated: September 01, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Onkos Surgical, Inc.
Quantity: 77 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for breach of Tyvek seals.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for breach of Tyvek seals.

Code information

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.

Distribution pattern

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.

device · product 5 of 6

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 SEGMENTAL LIMB SALVAGE SYSTEM

Z-1883-2025

Recall number: Z-1883-2025
Initiated: September 01, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Onkos Surgical, Inc.
Quantity: 233 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for breach of Tyvek seals.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for breach of Tyvek seals.

Code information

a. Model Number: HC-09100-03M; UDI-DI: 278HC0910003M0; Lot Numbers: 1880652, 1880653, 1880654, 1880655, 1880656, 1880657, 1880658, 1880659, 1880660, 1880661, 1880662, 1880663, 1880664, 1880665, 1880666, 1880667, 1880668, 1880669, 1880670, 1880671, 1880672, 1880673, 1880674, 1880675, 1880676, 1880677, 1880678, 1880679, 1880680, 1880681, 1880682, 1880683, 1880684, 1880685. b. Model Number: HC-10100-03M; UDI-DI: B278HC1010003M0; Lot Numbers: 1880686, 1880687, 1880688, 1880689, 1880690, 1880691, 1880692, 1880693, 1880694, 1880695, 1880696, 1880697, 1880698, 1880699, 1880700, 1880701, 1880702, 1880703, 1880704, 1880705, 1880706, 1880707, 1880708, 1880709, 1880710, 1880711, 1880712, 1880713, 1880714. c. Model Number: HC-11120-03M; UDI-DI: B278HC1112003M0; Lot Numbers: 1880715, 1880716, 1880717, 1880718, 1880719, 1880720, 1880721, 1880722, 1880723, 1880724, 1880725, 1880726, 1880727, 1880728, 1880729, 1880730, 1880731, 1880732, 1880733, 1880734, 1880735, 1880736, 1880737, 1880738, 1880739, 1880740, 1880741, 1880742, 1880743, 1880744, 1880745, 1880746, 1880747, 1880748, 1880749, 1880750, 1880751, 1880752, 1880753, 1880754, 1880755, 1880756, 1880757, 1880758, 1880759, 1880760, 1880761, 1880762, 1880763, 1880764, 1880765. d. Model Number: HC-13120-03M; UDI-DI: B278HC1312003M1; Lot Numbers: 1880766, 1880767, 1880768, 1880769, 1880770, 1880771, 1880772, 1880773, 1880774, 1880775, 1880776, 1880777, 1880778, 1880779, 1880780, 1880781, 1880782, 1880783, 1880784, 1880785, 1880786, 1880787, 1880788, 1880789, 1880790, 1880791, 1880792, 1880793, 1880794, 1880795, 1880796, 1880797, 1880798, 1880799, 1880800, 1880801, 1880802, 1880803, 1880804, 1880805, 1880806, 1880807, 1880808, 1880809, 1880810, 1880811. e. Model Number: HC-15120-03M; UDI-DI: B278HC1512003M0; Lot Numbers: 1880812, 1880813, 1880814, 1880815, 1880816, 1880817, 1880818, 1880819, 1880820, 1880821, 1880822, 1880823, 1880824, 1880825, 1880826, 1880827, 1880828, 1880829, 1880830, 1880831, 1880832, 1880833, 1880834, 1880835, 1880836, 1880837, 1880838, 1880839, 1880840, 1880841, 1880842, 1880843, 1880844, 1880845, 1880846, 1880847. f. Model Number: HC-17120-03M; UDI-DI: ; Lot Numbers: 1880848, 1880849, 1880850, 1880851, 1880852, 1880853, 1880854, 1880855, 1880856, 1880857, 1880858, 1880859, 1880860, 1880861, 1880862, 1880863, 1880864, 1880865, 1880866, 1880867, 1880868, 1880869, 1880870, 1880871, 1880872, 1880873, 1880874, 1880875, 1880876, 1880877, 1880878, 1880879, 1880880, 1880881, 1880882, 1880883, 1880884.

Distribution pattern

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.

device · product 6 of 6

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; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

Z-1884-2025

Recall number: Z-1884-2025
Initiated: September 01, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Onkos Surgical, Inc.
Quantity: 99 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for breach of Tyvek seals.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for breach of Tyvek seals.

Code information

a. Model Number: 25001040E; UDI-DI: B27825001040E0; Lot Numbers: 1802695, 1813688, 1823008, 1833874, 1841365, 1844552, 1855654, 1855799, 1856873, 1856874, 1860075, 1860076, 1880172, 1880173, 1880174, 1880175, 1880176, 1880177, 1880178, 1880179, 1880180, 1880181, 1880182. b. Model Number: 25001050E; UDI-DI: B27825001050E0; Lot Numbers: 1880183, 1880184, 1880185, 1880186, 1880187, 1880188, 1880189, 1880190, 1880191, 1880192, 1880193, 1880194, 1880195, 1880196. c. Model Number: 25001060E; UDI-DI: B27825001060E0; Lot Numbers: 1880197, 1880198, 1880199, 1880200, 1880201, 1880202, 1880203, 1880204, 1880205. d. Model Number: 25001070E; UDI-DI: B27825001070E0; Lot Numbers: 1880206, 1880207, 1880208, 1880209, 1880210, 1880211, 1880212, 1880213, 1880214, 1880215, 1880216, 1880217. e. Model Number: 25001090E; UDI-DI: B27825001090E0; Lot Numbers: 1880218, 1880219, 1880220, 1880221, 1880222, 1880223, 1880224, 1880225, 1880226, 1880227, 1880228, 1880229, 1880230, 1880231, 1880232. f. Model Number: 25001110E; UDI-DI: B27825001110E0; Lot Numbers: 1880233, 1880234, 1880235, 1880236, 1880237, 1880238, 1880239, 1880240, 1880241, 1880242, 1880243, 1880244, 1880245. g. Model Number: 25001140E; UDI-DI: B27825001140E0; Lot Numbers: 1880246, 1880247, 1880248, 1880249, 1880250, 1880251, 1880252, 1880253, 1880254, 1880255, 1880256, 1880257, 1880258.

Distribution pattern

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.