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.
Read the official notice →- Date
- 2025-09-03
- Country
- United States
- Brand
- Onkos Surgical
- Product
- ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Onkos Surgical recalls
- 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 →- 2025-07-09
- 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 →
Other drugs & medical recalls in the United States
- 2025-09-03
- US
VANTIVE US HEALTHCARE LLC recalls TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
- US
VANTIVE US HEALTHCARE LLC recalls PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853:…
- US
VANTIVE US HEALTHCARE LLC recalls PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
- US
Dentsply IH, Inc. recalls Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis…
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to…
FDA · DeviceDentsply IH, Inc.Worldwide - US Nationwide distribution in the states of IL, LA, MA, MN, MO,…Official notice → - US
MAQUET GMBH recalls Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software…
Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from…
FDA · DeviceMAQUET GMBHWorldwide - US Nationwide distribution in the states of KY, NY, TX and the…Official notice → - US
THOR Photomedicine Ltd recalls Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The…
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
FDA · DeviceTHOR Photomedicine LtdWorldwide distribution: US (nationwide): AK, AZ, CA, CO, CT, FL, GA, HI, ID,…Official notice →