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Class 2 Device Recall Stryker Visum 300 |
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Date Initiated by Firm |
July 25, 2013 |
Date Posted |
August 21, 2013 |
Recall Status1 |
Terminated 3 on April 03, 2015 |
Recall Number |
Z-1992-2013 |
Recall Event ID |
65888 |
Product Classification |
Device, medical examination, ac powered - Product Code KZF
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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
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For Additional Information Contact |
972-410-7100
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Manufacturer Reason for Recall |
Potential incomplete final weld on the drop tube flange.
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FDA Determined Cause 2 |
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
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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.
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