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Terminated

Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Kyphon, Inc., Sunnyvale, Ca 94089

FDA Recall Z-0949-2008 · Posted 2008-02-05

Recalling FirmKyphon Inc
Recall StatusTerminated
Product CodeBSP
Date Initiated2006-04-25
Date Terminated2008-06-10
Product QuantityBy Lot Number : J6013101 = 150, Lot: J6033011 = 43

Reason for Recall

Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.

Firm Action

A customer advisory letter was sent on 4/25/06 to consignees. In some cases some were issued in person. Follow up with field representatives was also conducted. Both contacts involved providing IMPORTANT CHANGES IN INSTRUCTIONS FOR USE that are to be attached to the on site users documents. The recalling firm is updating future distribution with the new instructions for use.

Root Cause

Labeling design

Distribution Pattern

Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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