Z-2646-2017Class II

Eleos Limb Salvage System Segmental Stem, Canal Filling, Diameter 18Mm, Length 120Mm, Style Straight, Type...

Name: Z-2646-2017 Eleos Limb Salvage System Segmental Stem, Canal Filling, Diameter 18Mm, Length 120Mm, Style Straight, Type...
Creator: Onkos Surgical, Inc.
Published: 2017-05-23
License: https://open.fda.gov/license/

Onkos Surgical, Inc. / initiated 2017-05-23 / Terminated / root cause: manufacturing process

FDA source

Onkos Surgical, Inc. began a recall of ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E on 2017-05-23. FDA classified it as Class II and gives the reason as "The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2646-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-23
Posted: 2017-06-29
Terminated: 2018-06-27
Recalling firm: Onkos Surgical, Inc.
Product: Eleos Limb Salvage System Segmental Stem, Canal Filling, Diameter 18Mm, Length 120Mm, Style Straight, Type Canal Filling, Collar 25Mm, Ref 2500Sp18e
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Root cause tag: manufacturing process
FDA 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 [email protected] (973) 264-5400, M-F 8:30 am - 5:00 pm.
Quantity in commerce: 4 units
Distribution: AZ, IL & KS
Product codes and lots: LOT 1700558

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2646-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2646-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29
Z-2647-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29
Z-2648-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29

Product code KRO

K161520Class IIELEOS Limb Salvage SystemOnkos Surgical, Inc. / cleared 2016-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)