RecallDepth

ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E

Company
Onkos Surgical, Inc.
Recall Initiated
May 23, 2017
Terminated
June 27, 2018
Recall Number
Z-2648-2017
Quantity
4 units
Firm Location
Parsippany, NJ

Reason for Recall

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

Distribution

AZ, IL & KS

Lot / Code Info

LOT 1699599

Root Cause

Process control

Action Taken

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.

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