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Terminated

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

FDA Recall Z-2648-2017 · Posted None

Recalling FirmOnkos Surgical, Inc.
Recall StatusTerminated
Product CodeKRO
Date Initiated2017-05-23
Date Terminated2018-06-27
Product Quantity4 units

Reason for Recall

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

Firm 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 [email protected] (973) 264-5400, M-F 8:30 am - 5:00 pm.

Root Cause

Process control

Distribution Pattern

AZ, IL & KS

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 2016-10-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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