Z-2424-2025Class II

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

Name: Z-2424-2025 ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA...
Creator: Onkos Surgical, Inc.
Published: 2025-07-11
License: https://open.fda.gov/license/

Onkos Surgical, Inc. / initiated 2025-07-11 / Open, Classified

FDA source

Onkos Surgical, Inc. began a recall of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants on 2025-07-11. FDA classified it as Class II and gives the reason as "Unidentified substance of unknown impact was identified on devices during a retrospective evaluation". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2424-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-11
Posted: 2025-08-25
Recalling firm: Onkos Surgical, Inc.
Product: ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
FDA root cause: Under Investigation by firm
Action: An email dated 7/11/25 was sent to consignees notifying them of this recall. Distributors and sales personnel are to segregate and quarantine affected devices immediately and return a completed Product and Distribution Information Table to [email protected]. Affected devices are to be returned within two business days to Onkos Surgical. Consignees with any questions are to contact Matt Dufner with any questions at 267-566-4560 or [email protected]. An email dated 8/5/25 was sent to surgical consignees notifying them of this recall. Hospitals are to remove affected devices from their facilities, forwarding any affected devices remaining in their possession to their Onkos Sales Representative. Onkos Surgical is in the process of determining the root cause of this recall issue and is performing additional testing on returning devices. Consignees with any questions are to contact Matt Dufner at 267-566-4560 or [email protected].
Quantity in commerce: 15 units
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.
Product codes and lots: Model No. 2500CP16E; UDI: B2782500CP16E0; Lot No. All lots released prior to 2025-07-11.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2424-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2423-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-25
Z-2424-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-25
Z-2425-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-25

Product code JDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)