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.
This recall has been terminated (originally issued May 26, 2009).
- Company
- Stryker Communications Corp
- Recall Initiated
- May 8, 2009
- Posted
- May 26, 2009
- Terminated
- April 26, 2010
- Recall Number
- Z-1418-2009
- Quantity
- 230 headrests.
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution and Canada.
Lot / Code Info
All surgical tables with headrest, Catalog/Part #0788-300-012. No Lot numbers.
Root Cause
Device Design
Action Taken
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.