Onkos Surgical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2425-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.

Product Classification:

Class II

Date Initiated: July 11, 2025

Date Posted: September 3, 2025

Recall Number: Z-2425-2025

Event ID: 97343

Reason for Recall:

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

Status: Ongoing

Product Quantity: 554 units

Code Information:

Model No. KSP17100E, KSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E, KSP22100E; UDI: B278KSP17100E0, B278KSP17140E0, B278KSP18100E0, B278KSP18140E0, B278KSP20100E0, B278KSP20140E0, B278KSP22100E0; Lot No. All lots released prior to 2025-07-11.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated