FDA Recall Terminated

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.

Recall: Z-0182-2009 · Initiated September 5, 2008

Recall

Recall Number
Z-0182-2009
Event Number
49514
Firm
Stryker Communications Corp
FEI Number
3002975342
Product Code
FQO
Status
Terminated
Root Cause
Device Design
Initiated
September 5, 2008
Posted
October 22, 2008
Terminated
October 2, 2009
Address
1410 Lakeside Pkwy, # 100, Flower Mound, TX, 75028

Description

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.

Reason

Circlip component used to suspend flat panel and navigation arm system may become dislodged.

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.

Distribution

Nationwide and International Distribution

Quantity

705 units