Date Initiated by Firm | December 30, 2011 |
Date Posted | July 16, 2013 |
Recall Status1 |
Terminated 3 on January 08, 2014 |
Recall Number | Z-1737-2013 |
Recall Event ID |
64989 |
510(K)Number | K092420 |
Product Classification |
Orthosis, spinal pedicle fixation - Product Code MNI
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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 MA 01915-6516
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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 | 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 |
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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 = MNI
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