CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report

Eleos Segmental Limb Salvage System, Eleos Stem Extension recalled

Onkos Surgical is recalling Eleos Segmental Limb Salvage System, Eleos Stem Extension, Straight, Splined, Slotted, distributed nationwide in the US. The recall was initiated on 11 Jul 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled554 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2425-2025
FDA event ID: 97343
Recalling firm: Onkos Surgical, Parsippany, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 11 Jul 2025
FDA classified: 25 Aug 2025
Reported: 3 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Jul 2025	Recall initiated by company
25 Aug 2025	Classified by FDA	+45 days
3 Sep 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alaska Arizona California Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina New Jersey New York Ohio

Questions about this recall

Is Eleos Segmental Limb Salvage System, Eleos Stem Extension, Straight, Splined, Slotted recalled?

Yes. Onkos Surgical recalled Eleos Segmental Limb Salvage System, Eleos Stem Extension, Straight, Splined, Slotted on 11 Jul 2025. The recall is Class II and its status is Ongoing. Recall number Z-2425-2025.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Onkos Surgical

All 16

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025Device	CLASS II	Eleos Segmental Limb Salvage System, Eleos Bowed Canal Filling Stems recalled	Onkos Surgical	Other	Nationwide
3 Sep 2025Device	CLASS II	Eleos Segmental Limb Salvage System recalled by Onkos Surgical	Onkos Surgical	Other	Nationwide
9 Jul 2025Device	CLASS II	My3D Personalized Solutions Humeral Cup recalled by Onkos Surgical	Onkos Surgical	Processing Deviation	Nationwide
4 Jun 2025Device	CLASS II	Eleos Collar Stem, Cemented, Fluted recalled by Onkos Surgical	Onkos Surgical	Labeling Errors	Nationwide
4 Jun 2025Device	CLASS II	Segmental Stem, Canal Filling, Bowed, 1 EACH recalled by Onkos Surgical	Onkos Surgical	Packaging Defects	18 states

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