ClearanceBrief
Recall Z-1899-2009 ยท FQO Table, Operating-Room, Ac-Powered

Stryker Communications Corp

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

DateAug 26, 2009 (initiated Nov 13, 2008)
StatusTerminated
ReasonSurgical tables were produced using an unapproved tilt frame bushing.
Root causeNonconforming Material/Component
ActionStryker 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.
Quantity31
DistributionWorldwide Distribution -- United States (OR, IL, WA, CA, AR, TX, UT, SC and GA) and Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.