Z-1899-2009
Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with electro-hydraulically...
STRYKER Communications, Inc. / initiated 2008-11-13 / Terminated / root cause: manufacturing process
Stryker Communications Corp began a recall of Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control... on . The reason FDA records is "Surgical tables were produced using an unapproved tilt frame bushing". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1899-2009
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- STRYKER Communications, Inc.
- Product
- 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
- Product code
- FQO Table, Operating-Room, Ac-Powered
- Reason for recall
- Surgical tables were produced using an unapproved tilt frame bushing.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity in commerce
- 31
- Distribution
- Worldwide Distribution -- United States (OR, IL, WA, CA, AR, TX, UT, SC and GA) and Canada.
- Product codes and lots
- 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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
