FDA Medical Device Recalls (openFDA)
Onkos Surgical, Inc.: ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
- Recall number
- Z-2647-2017
- Recalling firm
- Onkos Surgical, Inc.
- Product
- ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
- Status
- Terminated
- Initiated
- 2017-05-23
- Posted
- not on file
- Terminated
- 2018-06-27
- Reason
- The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
- Root cause
- Process control
- Action
- On May 23, 2017 Onkos Surgical distributed Medical Device Recall notices to their customers via courier service. Customers were advised to return the affected parts within 2 business days to: Millstone Medical 8836 Polk Lane, Suite 100 Olive Branch, MS 38654 ATTN: Anwar Powell/Recalled Product (662) 892-3612 ext. 1809. Questions regarding this recall can be addressed to: Jan Triani Senior Director of Quality Assurance and Regulatory Affairs jtriani@onkossurgical.com (973) 264-5400, M-F 8:30 am - 5:00 pm.
- Quantity
- 4 units
- Distribution
- AZ, IL & KS
- Lot, serial or model codes
- LOT 1700559
- 510(k) numbers
- ["K161520"]
- PMA numbers
- not on file
- Product code
- KRO
- 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