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Class 2 Device Recall NFlex Stabilization System 200 mm |
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Date Initiated by Firm |
November 07, 2008 |
Date Posted |
February 03, 2009 |
Recall Status1 |
Terminated 3 on October 05, 2009 |
Recall Number |
Z-0967-2009 |
Recall Event ID |
50677 |
510(K)Number |
K072685
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Product Classification |
Pedicle screw spinal system - Product Code NPQ
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Product |
NFlex Stabilization System 200 mm, Catalog number NF60020-1.
spinal fusion surgery |
Code Information |
Lot number NF60003 exp 3/31/07 |
Recalling Firm/ Manufacturer |
Synthes Spine 1302 Wrights Ln E West Chester PA 19380-3417
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For Additional Information Contact |
Customer Relations 800-479-6329
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Manufacturer Reason for Recall |
the dimensional specifications are incorrect
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The recalling firm issued an e-mail on 11/18/08 to their sales force to inform them of the problem and the need to remove the product.The recalling firm issued Medical Device recall letters dated 11/19/08 to their customers to inform them of the problem and the need to return the product. Contact Synthes at 800-620-7025 ext. 7025 or 610-719-5750 for additional information. |
Quantity in Commerce |
1508 (total) |
Distribution |
Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = NPQ and Original Applicant = N SPINE, INC.
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