KyphXR 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.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Kyphon Inc
- Recall Initiated
- October 13, 2003
- Posted
- July 20, 2004
- Terminated
- March 8, 2004
- Recall Number
- Z-0147-04
- Quantity
- 771 syringes
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Devices for which sterility may be compromised as evidenced by a loss of package integrity.
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.
Lot / Code Info
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
Root Cause
Other
Action Taken
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.