Date Initiated by Firm |
September 05, 2008 |
Date Posted |
October 22, 2008 |
Recall Status1 |
Terminated 3 on October 02, 2009 |
Recall Number |
Z-0182-2009 |
Recall Event ID |
49514 |
Product Classification |
Ceiling-mounted device - Product Code FQO
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Product |
Circlip component of the Stryker Flat Panel and Navigation Arm System. Stryker Flat Panel and Navigation Arm System are intended for use as a ceiling-mounted device to support a medical grade flat panel monitor or camera in the patient area. The Circlip within the flat panel and navigation arms is part of the mechanical stop designed to prevent the arm from rotating infinitely. It also prevents the cables routed through the arm from becoming twisted during routine movement and rotation of the arm. |
Code Information |
Part numbers: 0682-000-005 (A-O), 0682-000-200, 0682-000-270, 0682-000-280, 0682-000-281, 0682-000-850, and 0682-000-851. All units distributed between December 23, 2003 and September 30, 2006. |
Recalling Firm/ Manufacturer |
Stryker Communications Corp 1410 Lakeside Pkwy # 100 Flower Mound TX 75028
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For Additional Information Contact |
972-410-7310
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Manufacturer Reason for Recall |
Circlip component used to suspend flat panel and navigation arm system may become dislodged.
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FDA Determined Cause 2 |
Device Design |
Action |
Notification letter was sent to consignees September 5, 2008. Field service will be performed at all affected sites. Old Circlips will be replaced with new clamps that do not allow the arm to fall. Contact Stryker Communications Corp. at 1-972-410-7310 for assistance. |
Quantity in Commerce |
705 units |
Distribution |
Nationwide and International Distribution |
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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