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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-2116-2018 - Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
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2
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06/07/2018
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Orthofix, Inc
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Z-2135-2018 - Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
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2
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06/07/2018
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Orthofix, Inc
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Z-2118-2018 - Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
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2
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06/07/2018
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Orthofix, Inc
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Z-2119-2018 - Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010);
c) D 2.0MM X 12MM (002-D-20012);
d) D 2.0...
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2
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06/07/2018
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Orthofix, Inc
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Z-2120-2018 - Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010);
c) D 2.0MM X 12MM (002-E-20012); ...
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2
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06/07/2018
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Orthofix, Inc
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Z-2121-2018 - Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008);
b) D 2.7MM X 10MM (002-D-27010);
c) D 2.7MM X 12MM (002-D-2...
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2
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06/07/2018
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Orthofix, Inc
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Z-2122-2018 - Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008),
b) D 2.7MM X 10MM (002-E-27010);
c) D 2.7MM X 12MM (002-E-27012);
d) D 2.7MM X 1...
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2
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06/07/2018
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Orthofix, Inc
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Z-2123-2018 - Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010)
b) D 3.2MM X 12MM (002-D-32012)
c) D 3.2MM X 14MM (002-D-32014)
d) D 3.2MM X ...
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2
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06/07/2018
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Orthofix, Inc
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Z-2124-2018 - Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010)
b) D 3.2MM X 12MM (002-E-32012)
c) D 3.2MM X 14MM (002-E-32014)
d) D 3.2MM X 16M...
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2
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06/07/2018
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Orthofix, Inc
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Z-2125-2018 - Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001);
b) 22MM (003-F-22001);
c) 30MM (003-F-30001)
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2
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06/07/2018
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Orthofix, Inc
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