FDA
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
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.