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.
This recall has been terminated (originally issued October 22, 2008).
- Company
- Stryker Communications Corp
- Recall Initiated
- September 5, 2008
- Posted
- October 22, 2008
- Terminated
- October 2, 2009
- Recall Number
- Z-0182-2009
- Quantity
- 705 units
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Circlip component used to suspend flat panel and navigation arm system may become dislodged.
Distribution
Nationwide and International Distribution
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.
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