VERTIER Surgical Table, Catalog #0788-100-001S (SIDNE-enabled standard table with 5th wheel); 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.
This recall has been terminated (originally issued September 18, 2008).
- Company
- Stryker Communications Corp
- Recall Initiated
- July 2, 2008
- Posted
- September 18, 2008
- Terminated
- January 7, 2010
- Recall Number
- Z-2379-2008
- Quantity
- 4 units.
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All lot codes/serial numbers.
Root Cause
Device Design
Action Taken
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.