X-STOP Interspinous Process Decompression (lPD) System recallZ-1765-2008 · Kyphon Inc · initiated Jan 30, 2008
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Kyphon Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-1765-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 30, 2008
- Posted by the FDA
- Sep 29, 2008
- Recalling firm
- Kyphon Inc
- Quantity
- 25,000
- Product code
- NQO
- FDA submissions
- P040001
- 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 description
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.
Code information (models, lots, serial numbers)
All units of the Catalog Numbers.
Other devices under the same FDA submission
7 devices cleared under P040001 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- X-STOP® Interspinous Spacer 1-3210Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate5 reports
- X-STOP® Interspinous Spacer 1-3212Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate2 reports
- X-STOP® Interspinous Spacer 1-3212Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate2 reports
- X-STOP® Interspinous Spacer 1-3208Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate1 report
- X-STOP® Interspinous Spacer 1-2212Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate1 report
- X-STOP® Interspinous Spacer 1-3208Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate1 report
- X-STOP® Interspinous Spacer 1-3206Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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