Onkos Surgical, Inc. recalls
Every recall we track for Onkos Surgical, Inc. — 15 in all, from 2023–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Onkos Surgical, Inc. more than tripled in 2025 (4, up from 1 in 2024).
All FDA recall records for Onkos Surgical, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 4 | 4 | 8 |
| 2024 | 0 | 0 | 0 | 1 | 1 |
| 2025 | 0 | 0 | 0 | 4 | 4 |
| 2026 (to date) | 0 | 0 | 1 | 1 | 2 |
Most common reasons for Onkos Surgical, Inc. recalls
What to do if you have a recalled Onkos Surgical, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Onkos Surgical, Inc. recalls
6 shown- Lower riskMedical device
Onkos Surgical, Inc. recalls Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Onkos Surgical recalls My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M due to being mixed up with incorrect customers. This affects 1 implant sold nationwide in North Carolina and California.
Onkos SurgicalJul 24, 2026 - UnratedMedical device
Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Onkos Surgical recalls ELEOS Segmental Limb Salvage System implants with unidentified substance. Affected models were sold before July 11, 2025. No remedy specified in recall notice.
Onkos SurgicalJul 11, 2025 - UnratedMedical device
Onkos Surgical, Inc. recalls My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained
Onkos Surgical recalls My3D Humeral Cup model C24-0223-0003 due to missing required inspections before release, potentially causing injury. Affected users should contact the company for details.
Onkos SurgicalMay 20, 2025 - UnratedMedical device
Onkos Surgical, Inc. recalls ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Onkos Surgical recalls ELEOS MALE-FEMALE MIDSECTION 40MM (Part 25001040E) due to potential assembly issues during surgery. Affected units have specific lot numbers and UDI-DI codes.
Onkos SurgicalSep 22, 2024 - Lower riskMedical device
Onkos Surgical, Inc. recalls ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with
Onkos Surgical recalls ELEOS Collar Stem (HC-15120-03M) due to mislabeling as 13mm when it's 15mm. This could lead to improper implant fitting during surgery. Affected units have specific model and serial numbers.
Onkos SurgicalDec 22, 2023 - UnratedMedical device
Onkos Surgical, Inc. recalls a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem,
Onkos Surgical recalls specific segmental stem implants due to potential breach of Tyvek seals. Affected models include CS-09100-03M, CS-10100-03M, and others with listed lot numbers. No remedy provided in recall notice.
Onkos SurgicalSep 1, 2023
Onkos Surgical, Inc. recall questions
How many recalls has Onkos Surgical, Inc. had?
15 recalls from Onkos Surgical, Inc. are on record with U.S. safety agencies, from 2023–2026.
What is the most recent Onkos Surgical, Inc. recall?
Onkos Surgical, Inc. recalls Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M, dated Jul 24, 2026. Every Onkos Surgical, Inc. recall is listed on this page, newest first.
Why are Onkos Surgical, Inc. products recalled?
The most common reasons on record: Potential for breach of Tyvek seals. (6).
What should I do if I have a recalled Onkos Surgical, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Onkos Surgical, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.