Recall Z-1699-2017— Stryker Communications

Name: FDA recall Z-1699-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-28

Class II · Terminated

Class II FDA medical device recall by Stryker Communications, initiated 2017-02-28, terminated 2018-01-08. It names one FDA 510(k) clearance: K060802. Product: The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 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), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Reason: The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall..

Recalling firm: Stryker Communications
Classification: Class II
Status: Terminated
Initiated: 2017-02-28
Terminated: 2018-01-08
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

The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 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), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light

Reason for recall

The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall.

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