Parsippany, NJ, United States
Onkos Surgical, Inc. recalls
6 recalls recorded since 2018, most recently on 24 July 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)6
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 July 2026
- Reason
- Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
- Distribution
- US Nationwide distribution in the states of North Carolina, and California.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0091-2027, Z-0090-2027
- Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
- Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Ongoing Class II Medical devices
- Recall started
- 11 July 2025
- Reason
- Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- Distribution
- US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2425-2025, Z-2424-2025, Z-2423-2025
- ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
- ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
- ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Ongoing Class II Medical devices
- Recall started
- 20 May 2025
- Reason
- Required inspections were not performed on finished product prior to release and distribution.
- Distribution
- US Nationwide distribution in the state of Maryland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2042-2025
- My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Ongoing Class II Medical devices
- Recall started
- 22 September 2024
- Reason
- Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1857-2025
- ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Ongoing Class II Medical devices
- Recall started
- 22 December 2023
- 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 were mislabeled as size 13mm cemented stems.
- Distribution
- US Nationwide distribution in the states of California, Kentucky, and Wisconsin.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1818-2025, Z-1817-2025
- ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
- ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Ongoing Class II Medical devices
- Recall started
- 1 September 2023
- Reason
- Potential for breach of Tyvek seals.
- Distribution
- Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1879-2025, Z-1883-2025, Z-1881-2025, Z-1880-2025, Z-1884-2025, Z-1882-2025
- a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-
- 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-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
- 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, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-
- Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
- Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female
- 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-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.