CLASS II Device recall · Reported 5 Jul 2017 · FDA Enforcement Report
Eleos Limb Salvage System Segmental Stem, Canal Filling recalled
Onkos Surgical is recalling Eleos Limb Salvage System Segmental Stem, Canal Filling, Diameter, Length, Style Straight, distributed in Arizona, Illinois, Kansas. The recall was initiated on 23 May 2017 and the FDA has classified it as Class II.
Check your package
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-2648-2017
- FDA event ID
- 77309
- Recalling firm
- Onkos Surgical, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2017
- FDA classified
- 29 Jun 2017
- Reported
- 5 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 23 May 2017 | Recall initiated by company | |
| 29 Jun 2017 | Classified by FDA | +37 days |
| 5 Jul 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Product as listed by the FDA
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
Where it was distributed
AZ, IL & KS
Questions about this recall
Why was it recalled?
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Which lots are affected?
LOT 1699599
Where was it sold?
AZ, IL & KS
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 77309| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Eleos Limb Salvage System Segmental Stem, Canal Filling recalled | Onkos Surgical | Labeling Errors | AZ, IL, KS | |
| CLASS II | Eleos Limb Salvage System Segmental Stem, Canal Filling recalled | Onkos Surgical | Labeling Errors | AZ, IL, KS |
More recalls from Onkos Surgical
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Eleos Segmental Limb Salvage System, Eleos Bowed Canal Filling Stems recalled | Onkos Surgical | Other | Nationwide |
| Device | CLASS II | Eleos Segmental Limb Salvage System recalled by Onkos Surgical | Onkos Surgical | Other | Nationwide |
| Device | CLASS II | Eleos Segmental Limb Salvage System, Eleos Stem Extension recalled | Onkos Surgical | Other | Nationwide |
| Device | CLASS II | My3D Personalized Solutions Humeral Cup recalled by Onkos Surgical | Onkos Surgical | Processing Deviation | Nationwide |
| Device | CLASS II | Eleos Collar Stem, Cemented, Fluted recalled by Onkos Surgical | Onkos Surgical | Labeling Errors | Nationwide |
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| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |