Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1418-2009

Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part...

STRYKER Communications, Inc. / initiated 2009-05-08 / Terminated / root cause: design

Stryker Communications Corp began a recall of Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by... on . The reason FDA records is "Potential for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the VERTIER Surgical Table". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1418-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STRYKER Communications, Inc.
Product
Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by Stryker Communications, Flower Mound, TX 75028. The Vertier surgical table is intended for use in general surgery or diagnostic examinations to position a patient. The Vertier Surgical Table is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. The headrest is included with each table.
Product code
FQO Table, Operating-Room, Ac-Powered
Reason for recall
Potential for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the VERTIER Surgical Table.
Root cause tag
design
FDA root cause
Device Design
Action
An "URGENT: Device Recall" letter dated May 11, 2009 was issued to consignees. Consignees were informed that Stryker service representatives will visit each location to affix a caution label identifying the pinch point on each headrest. Additionally, consignees will be provided with an updated surgical table user manual. Direct questions to Stryker Communications Corporation by calling 972-410-7100.
Quantity in commerce
230 headrests.
Distribution
Nationwide Distribution and Canada.
Product codes and lots
All surgical tables with headrest, Catalog/Part #0788-300-012. No Lot numbers.