X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 160010

FDA device recall Z-1765-2008 · posted 2008-09-29 · Terminated

Recall details

Recalling firm

Kyphon Inc

Reason for recall

Physician instructions revised due to product breakage: During the implantation of the X-STOP IPD Device, the product has the potential to cause damage to and/or breakage of the X-STOP IPD Device's universal wing assembly. This includes the potential for breakage of the wing screw.

Action taken

On January 30, Kyphon sent a letter to all consignees, and a teleconference was held with sales management informing them of the recall and the need to contact consignees. The product labeling including the Physician Training and Physician's Guide have been updated to reflect the potential risk of breakage.

Root cause

Labeling design

Status

Terminated

Product code

NQO

Quantity affected

25,000

Distribution

Worldwide distribution: USA, UK, Netherlands, Canada, Australia, Denmark, Germany, Greece, Hong Kong, Israel, Italy, Philippines, Portugal, Singapore, South Africa, Spain Switzerland, Turkey and UAE.

Date initiated

2008-01-30

Date posted

2008-09-29

Date terminated

2009-07-14

Location

Sunnyvale, CA