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

Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.

FDA Recall Z-1605-2010 · Posted 2010-05-14

Recalling FirmStryker Communications Corp
Recall StatusTerminated
Product CodeBRY
Date Initiated2010-04-07
Date Terminated2011-03-30
Product Quantity1498

Reason for Recall

Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel.

Firm Action

An Urgent: Medical Device Recall letter dated April 19, 2010 was sent to customers. It was recommended that customers continue use of the product unless the monitor becomes unlevel. The customer was notified that a Stryker Representative would contact their facility to coordinate a service call to inspect the affected units. Questions are directed to the firm via phone at 972-410-7617 or via email at .

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide --US and Canada, Australia, China (Hong Kong), Latin America (Mexico, Chile, Ecuador, Costa Rica) .

Official Source

View FDA Recall →

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

↑