Recall Z-1882-2025— Onkos Surgical, Inc.

Name: FDA recall Z-1882-2025
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: K161520. Product: Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS 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

K161520 — ELEOS Limb Salvage SystemOnkos Surgical, Inc.·cleared 2016-10-28

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

Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS 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.