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U.S. Department of Health and Human Services

Class 2 Device Recall KyphX Xpander

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  Class 2 Device Recall KyphX Xpander see related information
Date Initiated by Firm October 13, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on March 08, 2004
Recall Number Z-0146-04
Recall Event ID 27597
510(K)Number K011811  
Product Classification Injector And Syringe, Angiographic - Product Code DXT
Product KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A.
Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray. The Inflation Syringe packaging and contents are identical whether provided as a stand-alone package or as a component of the KyphoPak Tray.
Code Information Merit Medical (Inflation Syringe): Part No.: K05-01290A, Lot Nos.:A284998, A282736*; Kyphon (Inflation Syringe), Catalog No.: A08A, Lot Nos.: A284998, A282736.  *Although Merit Medical''s notice of the recall involved three (3) lot numbers, one of the lots had already been returned by Kyphon to Merit Medical upon Kyphon''s discovery during incoming inspection that there was a problem with the packaging. So, Kyphon''s product removal only involved the two (2) additional lots of syringes, only portions of which were distributed to customers. 
Recalling Firm/
Manufacturer		 Kyphon Inc
1350 Bordeaux Dr
Sunnyvale CA 94089-1005
For Additional Information Contact Beth Rothwell
408-548-6500
Manufacturer Reason
for Recall		 Devices for which sterility may be compromised as evidenced by a loss of package integrity.
FDA Determined
Cause 2		 Other
Action On October 13, 2003, all consignees were notified via letter and on-site visit by a Kyphon sales representative, informing them of the affected devices and providing instructions on the recall.
Quantity in Commerce 211 syringes
Distribution There were a total of 188 direct customers that received the recalled product distributed by Kyphon. There were 0 (zero) wholesaler dealers, distributors, retailers that received the recalled product distributed by Kyphon. The recalled product was distributed in the United States only. Recalled product was distributed by Kyphon to one VA hospital, VA Medical Center of San Diego, 3350 La Jolla Village Dr. San Diego, CA 92161. There were no shipments to foreign or Canadian distribution.
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.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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