Recall Z-2647-2017 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Onkos Surgical, Inc.
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
| Date | May 23, 2017 |
| Status | Terminated |
| Reason | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm |
| 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 jtriani@onkossurgical.com (973) 264-5400, M-F 8:30 am - 5:00 pm. |
| Quantity | 4 units |
| Distribution | AZ, IL & KS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161520 | ELEOS Limb Salvage System Onkos Surgical, Inc., Oct 28, 2016 |