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Onkos Surgical, Inc. FDA Recalls
13 recalls on file across devices, 0 of them Class I and 13 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filliClass IIJul 11, 2025Unidentified substance of unknown impact was identified on d |
| ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.Class IIJul 11, 2025Unidentified substance of unknown impact was identified on d |
| ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.Class IIJul 11, 2025Unidentified substance of unknown impact was identified on d |
| My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained ShoClass IIMay 20, 2025Required inspections were not performed on finished product |
| ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage SystemClass IISep 22, 2024Potential challenge with intraoperative assembly of the exte |
| ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System withClass IIDec 22, 2023Mislabeling of 13mm Modular Segmental Stem package (HC-13120 |
| ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System withClass IIDec 22, 2023Mislabeling of 13mm Modular Segmental Stem package (HC-13120 |
| Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Class IISep 1, 2023Potential for breach of Tyvek seals. |
| a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, CClass IISep 1, 2023Potential for breach of Tyvek seals. |
| Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03Class IISep 1, 2023Potential for breach of Tyvek seals. |
| Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03Class IISep 1, 2023Potential for breach of Tyvek seals. |
| Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model NumClass IISep 1, 2023Potential for breach of Tyvek seals. |
| Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-1412Class IISep 1, 2023Potential for breach of Tyvek seals. |