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U.S. Department of Health and Human Services

Class 2 Device Recall TI NHance Rod 150 mm

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 Class 2 Recall
TI NHance Rod 150 mm
see related information
Date Posted February 03, 2009
Recall Status1 Terminated on October 05, 2009
Recall Number Z-0966-2009
Recall Event ID 50677
Premarket Notification
510(K) Numbers
K061774  K072685 
Product Classification Posterior Metal/Polymer Spinal System, Fusion - Product Code NQP
Product TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S spinal fusion surgery
Code Information Lot number: 5764185 exp 5/20/2013
Recalling Firm/
Manufacturer
Synthes Spine
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
For Additional Information Contact Customer Relations
800-479-6329
Manufacturer Reason
for Recall
the dimensional specifications are incorrect
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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

 
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.
510(K) Database 510(K)s with Product Code = NQP and Original Applicant = N SPINE, INC.
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