FDA Medical Device Recalls (openFDA)
Onkos Surgical, Inc.: ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
- Recall number
- Z-2425-2025
- Recalling firm
- Onkos Surgical, Inc.
- Product
- ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
- Status
- Open, Classified
- Initiated
- 2025-07-11
- Posted
- 2025-08-25
- Terminated
- not on file
- Reason
- Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- 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 mdufner@onkossurgical.com. 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 mdufner@onkossurgical.com. 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 mdufner@onkossurgical.com.
- Quantity
- 554 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K161520","K203588"]
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 3013450937
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28