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.
- Company
- Stryker Communications
- Recall Initiated
- November 13, 2018
- Recall Number
- Z-1388-2019
- Quantity
- 3,176 devices
- Firm Location
- Flower Mound, TX
Reason for Recall
There is a potential the joint in the suspension of the device is insufficiently assembled.
Distribution
Distribution was nationwide, including Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, France, India, Japan, Korea, Mexico, Netherlands, Spain and United Kingdom.
Lot / Code Info
Serial numbers 100000000065406 to 100000000106685.
Root Cause
Employee error
Action Taken
The recalling firm issued letters dated 11/13/2018 via FedEx informing to customers. The letter identified the affected product problem and actions to be taken. The customer is asked to disseminate the information within their organization. A response form was enclosed to indicate the customer has read and understands the instructions in the letter. The form was to be returned to the recalling firm via email. Customer was notified that a Stryker representative will begin visiting customer facilities in November to inspect their equipment. For questions contact " Stryker Technical Support at (800) 243-5135 or comm.techservices@stryker.com