| Class 2 Device Recall VERTIER Surgical Table |  |
Date Initiated by Firm | July 02, 2008 |
Date Posted | September 18, 2008 |
Recall Status1 |
Terminated 3 on January 07, 2010 |
Recall Number | Z-2379-2008 |
Recall Event ID |
49021 |
Product Classification |
Operating-Room Table - Product Code FQO
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Product | VERTIER Surgical Table, Catalog #0788-100-001S (SIDNE-enabled standard table with 5th wheel); distributed by Stryker Communications, Flower Mound, TX.
Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. |
Code Information |
All lot codes/serial numbers. |
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 | Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table. |
FDA Determined Cause 2 | Device Design |
Action | Urgent: Device Recall letters were sent to consignees on 07/02/08 via FedEx with return receipt. Consignees were asked to discontinue use of the tables until a Stryker representative has come to the facility and updated the table. The firm has identified and validated replacement parts that prevent this occurrence. |
Quantity in Commerce | 4 units. |
Distribution | Nationwide Distribution --- including states of AR, CA, FL, GA, ID, IL, IN, KS, KY, MN, MO, ND, NJ, NY, OH, OK, OR, SD, TX, UT, VA and Washington DC. |
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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