Recall Z-1897-2025— Silex Medical, LLC

Name: FDA recall Z-1897-2025
Creator: U.S. Food and Drug Administration
Published: 2024-01-09

Class II · Ongoing

Class II FDA medical device recall by Silex Medical, LLC, initiated 2024-01-09. It names one FDA 510(k) clearance: K914910. Product: Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.. Reason: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel..

Recalling firm: Silex Medical, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-01-09
Firm location: Southington, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K914910 — DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)Davol, Inc.·cleared 1992-01-06

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

Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.

Reason for recall

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

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