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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 Xpandersee related information
Date Initiated by FirmOctober 13, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on March 08, 2004
Recall NumberZ-0147-04
Recall Event ID 27597
Product Classification Injector And Syringe, Angiographic - Product Code DXT
ProductKyphXR brand KyphoPak Tray, a Introducer Tool kit for Inflation Syringe Kyphon Catalog Number: KPT1001, KPT1002, KPT1003, KPT1501, KPT1503, KPT2002, KPT2003 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 Kyphon (KyphoPak Tray) Introducer Tool kit: Catalog No. KPT1001 with Lot No. 03090901, Catalog No. KPT1002 with Lot No. 03090902, Catalog No. KPT1003 with Lot No. 03090903, Catalog No. KPT1501 with Lot No. 03091704, Catalog No. KTP1503 with Lot No. 03091705, Catalog No. KPT2002 with Lot No. 03090807, Catalog No. KPT2003 with Lot No. 03090806 
Recalling Firm/
Manufacturer		 Kyphon Inc
1350 Bordeaux Dr
Sunnyvale CA 94089-1005
For Additional Information ContactBeth 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
ActionOn 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 Commerce771 syringes
DistributionThere 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 CycleTPLC 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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