FDA recall Z-2424-2025

Onkos Surgical, Inc. · Class II · device

Product

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.

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.

Key facts

Status
Ongoing
Initiation date
2025-07-11
Report date
2025-09-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2424-2025