Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.
This recall has been terminated (originally issued May 14, 2010).
- Company
- Stryker Communications Corp
- Recall Initiated
- April 7, 2010
- Posted
- May 14, 2010
- Terminated
- March 30, 2011
- Recall Number
- Z-1605-2010
- Quantity
- 1498
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel.
Distribution
Worldwide --US and Canada, Australia, China (Hong Kong), Latin America (Mexico, Chile, Ecuador, Costa Rica) .
Lot / Code Info
Catalog number: 0682400028 Lot numbers 1003, 1004, 1005, 1006. Serial numbers from 00001-01529
Root Cause
Nonconforming Material/Component
Action Taken
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 .