Onkos Surgical
FDA adverse event reports naming Onkos Surgical as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ONKOS SURGICAL.
- Total reports
- 2,047
- Deaths
- 41
- Injuries
- 1,855
- Malfunctions
- 151
Reports per year
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO1,861
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH96
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI39
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY26
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH7
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWT5
- Tray, Surgical, InstrumentFSM4
- Prosthesis, Elbow, Hemi-, Humeral, MetalKWJ2
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2
- Screw, Fixation, BoneHWC1
Recent recalls
- 2025-08-25Open, ClassifiedUnder Investigation by firm
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- 2025-08-25Open, ClassifiedUnder Investigation by firm
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- 2025-08-25Open, ClassifiedUnder Investigation by firm
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- 2025-06-27Open, ClassifiedProcess control
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Required inspections were not performed on finished product prior to release and distribution.
- 2025-05-29Open, ClassifiedPackaging change control
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
Potential for breach of Tyvek seals.
- 2025-05-29Open, ClassifiedPackaging change control
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
Potential for breach of Tyvek seals.
- 2025-05-29Open, ClassifiedPackaging change control
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
Potential for breach of Tyvek seals.
- 2025-05-29Open, ClassifiedPackaging change control
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
Potential for breach of Tyvek seals.
- 2025-05-29Open, ClassifiedPackaging change control
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
Potential for breach of Tyvek seals.
- 2025-05-29Open, ClassifiedPackaging change control
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
Potential for breach of Tyvek seals.
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