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
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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
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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 |
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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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