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Terminated

KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.

FDA Recall Z-1209-2009 · Posted 2009-05-11

Recalling FirmMedtronic Spine LLC, formerly Kyphon Inc
Recall StatusTerminated
Product CodeHRX
Date Initiated2009-02-04
Date Terminated2009-07-14
Product Quantity10 units affected.

Reason for Recall

Product not sterile: 10 units were released for distribution without undergoing sterilization process.

Firm Action

Sales representatives were contacted via e-mail on February 4, 2009, and instructed to contact hospitals and inform them of the issue and sequester affected product. They were further instructed to immediately travel to the hospitals and obtain affected product for return to Medtronic LLC. A Customer Communication Notice URGENT NOTICE: DEVICE REMOVAL dated February 9, 2009, was sent to the two consignees.

Root Cause

Process change control

Distribution Pattern

Product was distributed to two hospitals in OH and FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041454KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13AKyphon, Inc. · 2004-07-09

Official Source

View FDA Recall →

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

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