Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2189-2008

Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER...

STRYKER Communications, Inc. / initiated 2008-05-01 / Terminated / root cause: design

Stryker Communications Corp began a recall of Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table distributed by Stryker Communications... on . The reason FDA records is "Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2189-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STRYKER Communications, Inc.
Product
Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table distributed by Stryker Communications, Flower Mound, TX 75028. The tables are AC-powered or air-powered devices intended for use during diagnostic examination or surgical procedures to support the patient.
Product code
FQO Table, Operating-Room, Ac-Powered
Reason for recall
Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in possible reduction or lose of function to hand and/or foot controls or possible involuntary movement of the table.
Root cause tag
design
FDA root cause
Device Design
Action
Firm notified consignees via letter titled URGENT: Device Recall, dated 04/01/08. Consignees notified of issue and were told a company representative would visit the firm to perform the required maintenance. Contact Karen Smith-Mosley at 972-410-7310 if you have questions.
Quantity in commerce
10 units.
Distribution
Nationwide distribution to the following states: CA, CO, TX and UT.
Product codes and lots
Lot/Serial #:070119-24045; 070119-24043; 070202-25062; 070319-27231; 070319-27232; 070202-25058; 071026-39230; 071026-39232; 070216-25279; and 071019-38649.