Onkos Surgical recalls
6 official recalls and safety alerts involving Onkos Surgical since 2025-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Onkos Surgical or the relevant agency.
- 2026-10-14
USOnkos Surgical, Inc. recalls Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the states of North Carolina, and California.Official notice →- 2025-09-03
- US
Onkos Surgical, Inc. recalls 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.
FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS,…Official notice → - 2025-07-09
- US
Onkos Surgical, Inc. recalls 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.
FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the state of Maryland.Official notice → - 2025-06-04
- US
Onkos Surgical, Inc. recalls a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight,…
Potential for breach of Tyvek seals.
FDA · DeviceOnkos Surgical, Inc.Product was shipped from Onkos' distribution in Olive Branch, MS to consignees…Official notice → - US
Onkos Surgical, Inc. recalls ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.Official notice → - US
Onkos Surgical, Inc. recalls ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
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…
FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the states of California, Kentucky, and Wisconsin.Official notice →