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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Table

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  Class 2 Device Recall Surgical Table see related information
Date Initiated by Firm May 01, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on January 08, 2010
Recall Number Z-2189-2008
Recall Event ID 48197
Product Classification Table, Operating-Room, Ac-powered - Product Code FQO
Product Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table distributed by Stryker Communications, Flower Mound, TX 75028. The tables are AC-powered or air-powered devices intended for use during diagnostic examination or surgical procedures to support the patient.
Code Information Lot/Serial #:070119-24045; 070119-24043; 070202-25062; 070319-27231; 070319-27232; 070202-25058; 071026-39230; 071026-39232; 070216-25279; and 071019-38649.
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		 Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in possible reduction or lose of function to hand and/or foot controls or possible involuntary movement of the table.
FDA Determined
Cause 2		 Device Design
Action Firm notified consignees via letter titled URGENT: Device Recall, dated 04/01/08. Consignees notified of issue and were told a company representative would visit the firm to perform the required maintenance. Contact Karen Smith-Mosley at 972-410-7310 if you have questions.
Quantity in Commerce 10 units.
Distribution Nationwide distribution to the following states: CA, CO, TX and UT.
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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