Recall Z-2647-2017— Onkos Surgical, Inc.

Name: FDA recall Z-2647-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-23

Class II · Terminated

Class II FDA medical device recall by Onkos Surgical, Inc., initiated 2017-05-23, terminated 2018-06-27. It names one FDA 510(k) clearance: K161520. Product: ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E. Reason: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm.

Recalling firm: Onkos Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-23
Terminated: 2018-06-27
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K161520 — ELEOS Limb Salvage SystemOnkos Surgical, Inc.·cleared 2016-10-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.