Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2376-2008

VERTIER Surgical Table, Catalog #0788-100-000 (Standard table); distributed by Stryker Communications, Flower...

STRYKER Communications, Inc. / initiated 2008-07-02 / Terminated / root cause: design

Stryker Communications Corp began a recall of VERTIER Surgical Table, Catalog #0788-100-000 (Standard table); distributed by Stryker Communications, Flower Mound, TX. Is an AC powered, general purpose... on . The reason FDA records is "Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2376-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STRYKER Communications, Inc.
Product
VERTIER Surgical Table, Catalog #0788-100-000 (Standard table); distributed by Stryker Communications, Flower Mound, TX. Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system.
Product code
FQO Table, Operating-Room, Ac-Powered
Reason for recall
Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.
Root cause tag
design
FDA root cause
Device Design
Action
Urgent: Device Recall letters were sent to consignees on 07/02/08 via FedEx with return receipt. Consignees were asked to discontinue use of the tables until a Stryker representative has come to the facility and updated the table. The firm has identified and validated replacement parts that prevent this occurrence.
Quantity in commerce
52 units.
Distribution
Nationwide Distribution --- including states of AR, CA, FL, GA, ID, IL, IN, KS, KY, MN, MO, ND, NJ, NY, OH, OK, OR, SD, TX, UT, VA and Washington DC.
Product codes and lots
All lot codes/serial numbers.