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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description 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.
Recall Number Z-1737-2013
Classification Class II
Code Info Lot Number: 002876-007R
Product Distributed Qty 2 rods
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.

Event Detail

Event Id 64989
Product Type Devices
Status Completed
Recalling Firm SpineFrontier, Inc.
City Beverly
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-12-30
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern USA Nationwide Distribution including the state of TX