Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1605-2010

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

STRYKER Communications, Inc. / initiated 2010-04-07 / Terminated / root cause: manufacturing process

Stryker Communications Corp began a recall of Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor on . The reason FDA records is "Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1605-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STRYKER Communications, Inc.
Product
Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.
Product code
BRY Cabinet, Table And Tray, Anesthesia
Reason for recall
Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
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 .
Quantity in commerce
1498
Distribution
Worldwide --US and Canada, Australia, China (Hong Kong), Latin America (Mexico, Chile, Ecuador, Costa Rica) .
Product codes and lots
Catalog number: 0682400028 Lot numbers 1003, 1004, 1005, 1006. Serial numbers from 00001-01529