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U.S. Department of Health and Human Services

Class 2 Device Recall Rods Pedicle screw spinal system

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 Class 2 Recall
Rods Pedicle screw spinal system
see related information
Date Posted July 16, 2013
Recall Status1 Terminated on January 08, 2014
Recall Number Z-1737-2013
Recall Event ID 64989
Premarket Notification
510(K) Number
K092420 
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
Product KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.
Code Information Lot Number: 002876-007R
Recalling Firm/
Manufacturer
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly, Massachusetts 01915-6516
For Additional Information Contact Nicole Baginski
978-232-3990
Manufacturer Reason
for Recall
One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control
Action SpineFrontier issued a Recall Notification to the affected distributor via telephone. The distributor was instructed to return the affected product for a replacement product.
Quantity in Commerce 2 rods
Distribution USA Nationwide Distribution including the state of TX
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 = MNI and Original Applicant = SPINEFRONTIER, INC.
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