Recall Z-1388-2019— Stryker Communications

Name: FDA recall Z-1388-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-13

Class II · Ongoing

Class II FDA medical device recall by Stryker Communications, initiated 2018-11-13. It names one FDA 510(k) clearance: K060802. Product: EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.. Reason: There is a potential the joint in the suspension of the device is insufficiently assembled..

Recalling firm: Stryker Communications
Classification: Class II
Status: Ongoing
Initiated: 2018-11-13
Firm location: Flower Mound, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K060802 — VISUM LED SURGICAL LIGHTING SYSTEMStryker Communications Corp.·cleared 2006-04-07

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

EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.

Reason for recall

There is a potential the joint in the suspension of the device is insufficiently assembled.

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