Onkos Surgical, Inc.: 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

Recall number

Z-1883-2025

Recalling firm

Onkos Surgical, Inc.

Product

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

Status

Open, Classified

Initiated

2023-09-01

Posted

2025-05-29

Terminated

not on file

Reason

Potential for breach of Tyvek seals.

Root cause

Packaging change control

Action

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.

Quantity

233 units

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.

Lot, serial or model codes

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.

510(k) numbers

["K203815"]

PMA numbers

not on file

Product code

JDI

Firm FEI

3013450937

Firm city

Parsippany

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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