🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: September 1, 2023 Onkos Surgical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Onkos Surgical, Inc.
Reason for Recall:
Potential for breach of Tyvek seals.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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:

Distributed in: MS, GA, TX, WA, LA, NJ, FL, AZ, MD, KS, IL, WI, KY, PA, NC, NE, OH, HI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1883-2025

Related Recalls