Z-1765-2008

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

Name: Z-1765-2008 X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N 16000789-01 (Ti device)...
Creator: Kyphon Inc
Published: 2008-01-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-01-30 / Terminated / root cause: labeling and UDI

FDA source

Kyphon Inc began a recall of X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device); Catalog numbers... on 2008-01-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1765-2008
Status: Terminated
Initiated: 2008-01-30
Posted: 2008-09-29
Terminated: 2009-07-14
Recalling firm: Medtronic, Inc.
Product: X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device); Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM X-STOP, 1-2208 US 8MM X-STOP, 1-2210 US 10MM X-STOP, 1-2212 US 12MM X-STOP, 1-2214 US 14MM X-STOP. Catalog numbers include for X-STOP PEEK Implant: 1-3206 US 6mm X STOPpk, 1-3208 US 8mm X STOPpk, 1-3210 US 10mm X STOPpk, 1-3212 US 12mm X STOPpk, 1-3214 US 14mm X STOPpk, 1-3216 US 16mm X STOPpk. Product is manufactured and distributed by Medtronic Spine LLC (formerly Kyphon Inc.); Spinal implants.
Product code: NQO Prosthesis, Spinous Process Spacer/Plate
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: All units of the Catalog Numbers.

Product code NQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)