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Class 2 Device Recall Vertier Surgical Table |
 |
| Date Initiated by Firm |
November 13, 2009 |
| Date Posted |
April 06, 2010 |
| Recall Status1 |
Terminated 3 on August 11, 2010 |
| Recall Number |
Z-1238-2010 |
| Recall Event ID |
53993 |
| Product Classification |
Table, Operating-Room, Ac-Powered - Product Code FQO
|
| Product |
Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S, 0788100001, and 0788100001S |
| Code Information |
All Lots Are Affected |
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 |
In certain positions, product is susceptible to fluid instrusion which could possibly result in short circuit or unsolicited movement.
|
FDA Determined
Cause 2 |
Other |
| Action |
Firm notified all consignees by letter sent 11/13/2009. Contact the firm at 972-410-7100 with questions relating to this recall. |
| Quantity in Commerce |
206 |
| Distribution |
United States (GA, AR, ND, KY, CO, CA, SD, PA, OH, TX, SC, NY, MS, IL, KS, NJ, OR, WA, MN, VA, IL, OK, WY, IN, ID, UT, MO, FL, and DC) and Canada. |
| 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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