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U.S. Department of Health and Human Services

Class 2 Device Recall Vertier Surgical Table

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  Class 2 Device Recall Vertier Surgical Table see related information
Date Initiated by Firm November 13, 2008
Date Posted August 26, 2009
Recall Status1 Terminated 3 on August 28, 2009
Recall Number Z-1899-2009
Recall Event ID 52712
Product Classification Table, operating-room, ac-powered - Product Code FQO
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
Code Information 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.
Recalling Firm/
Manufacturer		 Stryker Communications Corp
1410 Lakeside Pkwy Ste 100
Flower Mound TX 75028-4026
For Additional Information Contact
972-410-7310
Manufacturer Reason
for Recall		 Surgical tables were produced using an unapproved tilt frame bushing.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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