Recall Z-1883-2025— Onkos Surgical, Inc.

Name: FDA recall Z-1883-2025
Creator: U.S. Food and Drug Administration
Published: 2023-09-01

Class II · Ongoing

Class II FDA medical device recall by Onkos Surgical, Inc., initiated 2023-09-01. It names one FDA 510(k) clearance: K203815. Product: Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM. Reason: Potential for breach of Tyvek seals..

Recalling firm: Onkos Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-01
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K203815 — ELEOS Limb Salvage System with BioGripOnkos Surgical·cleared 2021-06-09

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

Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

Reason for recall

Potential for breach of Tyvek seals.

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