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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-2126-2018 - CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020);
b) Medium (002-G-01025);
c) Large (002-G-01030)
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2
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06/07/2018
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Orthofix, Inc
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Z-2127-2018 - Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006);
b) 8MM Spacer (022-H-00008);
c) 10MM Spacer (002-H-00010);
d) 12MM Spacer (002-H-0...
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2
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06/07/2018
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Orthofix, Inc
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Z-2128-2018 - H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number):
a) 12MM Spacer (003-H-12001);
b) 15MM Spacer (003-H-15001);
20MM Spacer (003-H-20001);
25MM Spacer (003-H-25001)...
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2
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06/07/2018
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Orthofix, Inc
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Z-2129-2018 - Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number):
a) Small/0MM Step/Left (002-C-01000L);
b) Small/0MM Step/Right (002-C-01000R);
c) Large/0MM...
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2
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06/07/2018
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Orthofix, Inc
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Z-2130-2018 - L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
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2
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06/07/2018
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Orthofix, Inc
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Z-2131-2018 - MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002);
c) Large (002-B-03003)
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2
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06/07/2018
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Orthofix, Inc
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Z-2132-2018 - Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)
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2
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06/07/2018
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Orthofix, Inc
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Z-2133-2018 - TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025);
c) Large (002-F-01030)
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2
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06/07/2018
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Orthofix, Inc
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Z-2134-2018 - T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
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2
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06/07/2018
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Orthofix, Inc
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Z-2117-2018 - Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
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2
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06/07/2018
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Orthofix, Inc
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