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ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL… recallZ-2423-2025 · Onkos Surgical, Inc. · initiated Jul 11, 2025

Class II Open, Classified All recalls posted in August 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Onkos Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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].

Recall details

Recall number
Z-2423-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jul 11, 2025
Posted by the FDA
Aug 25, 2025
Recalling firm
Onkos Surgical, Inc.
Quantity
30 units
Product code
JDI
FDA submissions
K161520, K203588
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 description

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

Code information (models, lots, serial numbers)

Model No. 2500BP20E, 2500BP22E; UDI: B2782500BP20E0, B2782500BP22E0; Lot No. All lots released prior to 2025-07-11.

Other devices under the same FDA submission

157 devices cleared under K161520, K203588 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97343).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page