Onkos Surgical recalls
Onkos Surgical appears in 18 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 18 |
|---|---|
| Published | 2017-07-05 to 2026-10-14 |
| By agency | FDA Device (18) |
| By classification | Class II (18) |
| By status | ongoing (15), terminated (3) |
| Distribution named in notices | AZ, FL, GA, HI, IL, KS, KY, LA, MD, MS, NC, NE, NJ, OH, PA, TX, US, WA, WI |
Recalls
- Onkos Surgical Inc
FDA Device · Class II · 2026-10-14 · Onkos Surgical
Reason: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. - Onkos Surgical Inc
FDA Device · Class II · 2026-10-14 · Onkos Surgical
Reason: Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. - ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants
FDA Device · Class II · 2025-09-03 · Onkos Surgical
Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. - ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants
FDA Device · Class II · 2025-09-03 · Onkos Surgical
Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. - ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants
FDA Device · Class II · 2025-09-03 · Onkos Surgical
Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. - My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003
FDA Device · Class II · 2025-07-09 · Onkos Surgical
Reason: Required inspections were not performed on finished product prior to release and distribution. - 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…
FDA Device · Class II · 2025-06-04 · Onkos Surgical
Reason: Potential for breach of Tyvek seals. - a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH
FDA Device · Class II · 2025-06-04 · Onkos Surgical
Reason: Potential for breach of Tyvek seals. - ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip
FDA Device · Class II · 2025-06-04 · Onkos Surgical
Reason: Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems… - ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
FDA Device · Class II · 2025-06-04 · Onkos Surgical
Reason: Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur. - Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH
FDA Device · Class II · 2025-06-04 · Onkos Surgical
Reason: Potential 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-14120-03M, FS-15120-03M…
FDA Device · Class II · 2025-06-04 · Onkos Surgical
Reason: Potential 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-14152-03M, FB-15152-03M, FB…
FDA Device · Class II · 2025-06-04 · Onkos Surgical
Reason: Potential for breach of Tyvek seals. - ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip
FDA Device · Class II · 2025-06-04 · Onkos Surgical
Reason: Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems… - Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS L…
FDA Device · Class II · 2025-06-04 · Onkos Surgical
Reason: Potential for breach of Tyvek seals. - ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM
FDA Device · Class II · 2017-07-05 · Onkos Surgical
Reason: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm - ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM
FDA Device · Class II · 2017-07-05 · Onkos Surgical
Reason: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm - ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF…
FDA Device · Class II · 2017-07-05 · Onkos Surgical
Reason: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm