Recall archive / FDA device enforcement

Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120... — FDA record Z-1883-2025

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. Source coverage and dates.

What the record says

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
Reason: Potential for breach of Tyvek seals.
Classification: Class II
Recalling firm: Onkos Surgical, Inc.
Quantity: 233 units
Agency-reported status: Ongoing
Source record identifier: Z-1883-2025

Open the official record

What the recall classes mean. 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: 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.

Label field

Details supplied by the agency

Lot, code or applicability

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.

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.

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 the record says

Lot and product identifiers

Distribution

Dates in the source

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