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

Hazard

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

Details from the source

Reason for recall: 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. Quantity: 554 units Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.