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U.S. Department of Health and Human Services

Class 2 Device Recall XSTOP

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 Class 2 Recall
XSTOP
see related information
Date Posted September 29, 2008
Recall Status1 Terminated on July 14, 2009
Recall Number Z-1765-2008
Recall Event ID 47490
Premarket Approval
PMA Number
P040001
Product Classification Prosthesis, Spinous Process Spacer/Plate - Product Code NQO
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.
Code Information All units of the Catalog Numbers.
Recalling Firm/
Manufacturer
Kyphon Inc
1221 Crossman Ave
Sunnyvale, California 94089-1103
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NQO and Applicant = KYPHON, INC.
PMAs with Product Code = NQO and Applicant = MEDTRONIC
PMAs with Product Code = NQO and Applicant = MEDTRONIC SOFAMOR DANEK, INC.
PMAs with Product Code = NQO and Applicant = MEDTRONIC SPINE LLC.
PMAs with Product Code = NQO and Applicant = ST. FRANCIS MEDICAL TECHNOLOGIES, INC.
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