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U.S. Department of Health and Human Services

Class 2 Device Recall Circlip

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 Class 2 Recall
Circlip
see related information
Date Posted October 22, 2008
Recall Status1 Terminated on October 02, 2009
Recall Number Z-0182-2009
Recall Event ID 49514
Product Classification Table, Operating-Room, Ac-Powered - Product Code FQO
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, Texas 75028
Manufacturer Reason
for Recall
Circlip component used to suspend flat panel and navigation arm system may become dislodged.
FDA Determined
Cause 2
DESIGN: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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