Class 2 Device Recall Stryker Visum 300

• Date Initiated by Firm: July 25, 2013
• Date Posted: August 21, 2013
• Recall Status: Terminated on April 03, 2015
• Recall Number: Z-1992-2013
• Recall Event ID: 65888
• Product Classification: Device, medical examination, ac powered - Product Code KZF
• Product: Stryker Visum 300 Ceiling-mounted Exam Light.
• Code Information: Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.
• Recalling Firm/ Manufacturer: Stryker Communications; 1410 Lakeside Pkwy Ste 100; Flower Mound TX 75028-4026
• For Additional Information Contact: 972-410-7100
• Manufacturer Reason for Recall: Potential incomplete final weld on the drop tube flange.
• FDA Determined Cause: Process control
• Action: The firm decided to recall and notified consignees with an "Urgent Medical Device Correction/Removal" notification letter dated 07/29/13. The product issue was described and recommended actions were provided. Customers may contact Stryker Technical Support at 866-841-5663.
• Quantity in Commerce: 1,375 units
• Distribution: Worldwide Distribution: US natiowide and to the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.