Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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.

FDA Recall Z-0182-2009 · Posted 2008-10-22

Recalling FirmStryker Communications Corp
Recall StatusTerminated
Product CodeFQO
Date Initiated2008-09-05
Date Terminated2009-10-02
Product Quantity705 units

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide and International Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑