ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM — Class II medical device recall Z-2647-2017
Terminated recall by Onkos Surgical, Inc., reported 2017-07-05, distributed in AZ, IL, KS. The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
| Recall number | Z-2647-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Onkos Surgical, Inc., Parsippany, NJ, United States |
| Recall initiated | 2017-05-23 |
| Classified | 2017-06-29 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2018-06-27 |
| Distributed | AZ, IL, KS |
| Quantity | 4 units |
| Reason classes | labeling |
| Lot numbers | 1700559 |
| Model numbers | 2500SP20E |
Product
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
Reason for recall
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2647-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.