Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0182-2009

Circlip component of the Stryker Flat Panel and Navigation Arm System. Stryker Flat Panel and Navigation Arm...

STRYKER Communications, Inc. / initiated 2008-09-05 / Terminated / root cause: design

Stryker Communications Corp began a recall of 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... on . The reason FDA records is "Circlip component used to suspend flat panel and navigation arm system may become dislodged". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0182-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STRYKER Communications, Inc.
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.
Product code
FQO Table, Operating-Room, Ac-Powered
Reason for recall
Circlip component used to suspend flat panel and navigation arm system may become dislodged.
Root cause tag
design
FDA root cause
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
Product codes and lots
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.