Recall Z-1879-2025— Onkos Surgical, Inc.

Name: FDA recall Z-1879-2025
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: a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. 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

a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. 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.