Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. Part Numbers: 0788100000 Standard table, 0788100001 Standard table with 5th wheel, 0788100000S SIDNE-enabled standard table, and 0788100001S SIDNE-enabled 5th wheel table
This recall has been terminated (originally issued August 26, 2009).
- Company
- Stryker Communications Corp
- Recall Initiated
- November 13, 2008
- Posted
- August 26, 2009
- Terminated
- August 28, 2009
- Recall Number
- Z-1899-2009
- Quantity
- 31
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Surgical tables were produced using an unapproved tilt frame bushing.
Distribution
Worldwide Distribution -- United States (OR, IL, WA, CA, AR, TX, UT, SC and GA) and Canada.
Lot / Code Info
Lot Numbers: 080111-43525, 080111-43526, 080111-43527, 080111-43528, 080118-43529, 080118-43530, 080118-43531, 080118-43532, 080118-43533, 080118-43537, 080118-43538, 080811-54955, 080811-54956, 080811-54957, 080811-54958, 080811-54959, 080811-54961, 080811-54962, 080811-54963, 080811-54964, 080811-54965, 080811-54966, 080811-54967, 080811-54968, 080811-54985, 080811-54986, 080811-54987, 080811-54988, 080811-54989, 080811-54998 and 080811-55002.
Root Cause
Nonconforming Material/Component
Action Taken
Stryker Communications issued an "Urgent: Medical Device Recall" notice dated November 13, 2008 informing Consignees of the affected product. The firm intends to contact each facility to coordinate service by a trained representative. For further information, contact Stryker at 1-972-410-7100.