FDAClass IIJuly 5, 2017

Eleos Limb Salvage System Segmental Stem recall

ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E

Why was Eleos Limb Salvage System Segmental Stem recalled?

The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LOT 1700559

Product
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
Recalling firm
Onkos Surgical, Inc.
Quantity
4 units
Distribution
AZ, IL & KS
Recall date
July 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls