Orthofix, Inc: Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

Agency Publication Date: June 7, 2018

Affected Products

Product: 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

UDI: 18056099648592, B1115657, B1107222, B1107223

Product: 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

UDI: 18056099648578, Lot: B1094193, B1104809, B1107372

Lot Numbers:

B1094193

Product: Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C

UDI: 18056099648608, Lot: B1107421,

Lot Numbers:

B1107421

Product: 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 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM (002-D-20018); g) D 2.0MM X 20MM (002-D-20020); h) D 2.0MM X 22MM (002-D-20022); i) D 2.0MM X 24MM (002-D-20024); j) D 2.0MM X 26MM (002-D-20026); k) D 2.0MM X 28MM (002-D-20028); l) D 2.0MM X 30MM (002-D-2003

(UDI)/Lot: a) (18056099645614) B1204542, B1101808; b) (18056099645621) B1204969, B1201169, B1075101; c) (18056099645638) B1204554, B1195701, B1075428; d) (18056099645645) B1204971, B1201176, B1075846; e) (18056099645652) B1195727, B1204266, B1075426; f) (18056099645669) B1204540, B1075429; g) (18056099645676) B1204541, B1075425; h) (18056099645683) B1204539, B1075177; i) (18056099645690) B1204972, B1195700, B1075847; j) (18056099645706) B1204555, B1195702, B1075427; k) (18056099645713) B1204973, B1201170, B1075430; l) (18056099645720) B1075825, B1201166, B1204270

Product: 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); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D 2.0MM X 18MM (002-E-20018); g) D 2.0MM X 20MM (002-E-20020); h) D 2.0MM X 22MM (002-E-20022); i) D 2.0MM X 24MM (002-E-20024); j) D 2.0MM X 26MM (002-E-20026); k) D 2.0MM X 28MM (002-E-20028); l) D 2.0MM X 30MM

(UDI)/Lot: a) (18056099646161)B1204974, B1089899, B1201171, B1201171; b) (18056099646178) B1195696, B1204268, B1083839; c) (18056099646185) B1215486, B1201172, B1201172, B1204281, B1083845; d) (18056099646192) B1215489, B1204975, B1083855, B1201173, B1201173; e) (18056099646208) B1215482, B1204585, B1195748, B1089887; f) (18056099646215) B1215488, B1204559, B1083856; g) (18056099646222) B1215483, B1204558, B1083854; h) (18056099646239) B1215490, B1204277, B1195721, B1083849; i) (18056099646246) B1215484, B1204279, B1195703, B1089890; j) (18056099646253) B1215491, B1204283, B1195720, B1083648; k) (18056099646260) B1215485, B1089879, B1201174, B1204267, B1204267; l) (18056099646277) B1215487, B1204284, B1195751, B1083857

Product: 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-27012); d) D 2.7MM X 14MM (002-D-27014); e) D 2.7MM X 16MM (002-D-27016); f) D 2.7MM X 18MM (002-D-27018); g) D 2.7MM X 20MM (002-D-27020); h) D 2.7MM X 22MM (002-D-27022); i) D 2.7MM X 24MM (002-D-27024); j) D 2.7MM X 26MM (002-D-27026); k) D 2.7MM X 28MM (002-D-27028); l) D 2.7MM

(UDI)/Lot: a) (8056099645782) B1075108; b) (18056099645799) B1075105 c) (18056099645805) B1071598, B1075178, B1075178; d) 18056099645812) B1069675, B1075431, B1075431; e) (18056099645829) B1071545, B1075435; f) (18056099645836) B1071540, B1075839; g) (18056099645843) B1068567, B1075827, B1075827; h) (18056099645850) B1082175, B1082175; i) (18056099645867) B1082237, B1068549, B1082237; j) (18056099645874) B1075060, B1082182; k) (18056099645881) B1068574, B1082236; l) (18056099645898) B1204990, B1071594, B1082232; m) (18056099645904) B1204993, B1071543, B1082222; n) (18056099645911) B1071542, B1195742, B1083645; o) (18056099645928) B1071539, B1083644, B1195708, B1083644; p) (18056099645935) B1204989, B1071541, B1089895; q) (18056099645942) B1069679, B1195752, B1069679, B1082235

Product: 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 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM (002-E-27018); g) D 2.7MM X 20MM (002-E-27020); h) D 2.7MM X 22MM (002-E-27022); i) D 2.7MM X 24MM (002-E-27024); j) D 2.7MM X 26MM (002-E-27026); k) D 2.7MM X 28MM (002-E-27028); l) D 2.7MM X 30MM (002-E-27030); m) D 2.7

(UDI)/Lot: a) (18056099646338) B1075104; b) (18056099646345) B1071537, B1083847; c) (18056099646352) B1068544, B1075103; d) (18056099646369) B1075176; e) (18056099646376) B1075838; f) (18056099646383) B1069676, B1082189; g) (18056099646390) B1071602, B1082231; h) (18056099646406) B1069678, B1084787; i) (18056099646413) B1071672, B1082227, B1071672, B1075052; j) (18056099646420) B1082238; k) (18056099646437) B1084801; l) (18056099646444) B1082214, B1204276; m) (18056099646451) B1215467, B1089836; n) (18056099646468) B1215470, B1089877; o) (18056099646475) B1215466, B1089894; p) (18056099646482) B1195749, B1082234; q) (18056099646499) B1204583, B1089842

Product: 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 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32020) g) D 3.2MM X 22MM (002-D-32022) h) D 3.2MM X 24MM (002-D-32024) i) D 3.2MM X 26MM (002-D-32026) j) D 3.2MM X 28MM (002-D-32028) k) D 3.2MM X 30MM (002-D-32030) l) D 3.2MM X 32MM (002-D-32032) m) D 3.2MM X 34M

(UDI)/Lot: a) (18056099645959) B1082246; b) (18056099645966) B1075836; c) (18056099645973) B1084806; d) (18056099645980) B1089892; e) (18056099645997) B1075845; f) (18056099646000) B1084797; g) (18056099646017) B1084792; h) (18056099646024) B1084799; i) (18056099646031) B1083858; j) (18056099646048) B1083859; k) (18056099646055) B1089891, B1195735; l) (18056099646062) B1195736, B1089882; m)(18056099646079) B1204992, B1083850; n) (18056099646086) B1083848, B1195699; o) (18056099646093) B1195732, B1089896; p) (18056099646109) B1204991, B1083642; q) (18056099646116) B1195739, B1083851; r) (18056099646123) B1204988, B1083637; s) (18056099646130) B1195733, B1089898; t) (18056099646147) B1195744, B1083838; u) (18056099646154) B1195730, B1071599, B1083853

Product: 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 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020) g) D 3.2MM X 22MM (002-E-32022) h) D 3.2MM X 24MM (002-E-32024) i) D 3.2MM X 26MM (002-E-32026) j) D 3.2MM X 28MM (002-E-32028) k) D 3.2MM X 30MM (002-E-32030) l) D 3.2MM X 32MM (002-E-32032) m) D 3.2MM X 34MM (

(UDI)/Lot: a) (18056099646505) B1075433; b) (18056099646512) B1075434; c) (18056099646529) B1075844; d) (18056099646536) B1075432; e) (18056099646543) B1075436; f) (18056099646550) B1075826; g) (18056099646567) B1075837; h) (18056099646574) B1084804; i) (18056099646581) B1075835; j) (18056099646598) B1082233; k) (18056099646604) B1204272, B1075829; l) (18056099646611) B1204977, B1082245; m) (18056099646628) B1215471, B1204978, B1082247; n) (18056099646635) B1204979, B1084800; o) (18056099646642) B1204582, B1082248; p) (18056099646659) B1218842, B1204980; q) (18056099646666) B1218840, B1204271, B1089889; r) (18056099646673) B1218843, B1195750, B1083640; s) (18056099646680) B1204981, B1083837; t) (18056099646697) B1204982, B1083846; u) (18056099646703) B1204584, B1083852, B1071600, B1071601

Product: 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)

(UDI)/Lot: a) (18056099647854) B1102026; b) (18056099647878) B1101930; c) (18056099647892) B1098806

Product: 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)

(UDI)/Lot: a) (18056099647694) B1099067; b) (18056099647700) B1099061; c) (18056099647717) B1099063

Product: 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-00012)

Lot: B1212604, Date of Manufacture: 2017-11-15, Use By: 2022-10-15, UDI: a) (18056099647724) B1099059, B1123627; b) (18056099647731) B1099057; c) (18056099647748) B1099068; d (18056099647755) B1099069

Lot Numbers:

B1212604

Product: 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); 30 MM (003-H-30001)

Lot: B1212400, Date of Manufacture: 2017-11-13, Use By: 2022-10-13, (UDI)/Lot: a) (18056099647908) B1096740; b) (18056099647915) B1096733; c) (18056099647939) B1096734; d) (18056099647953) B1096735; e) (18056099647960) B1100226

Lot Numbers:

B1212400

Product: 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 Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e) Small/2MM Step/Left (002-C-01002L); f) Small/2MM Step/Right (002-C-01002R); g) Large/2MM Step/Left (002-C-02002L); h) Large/2MM Step/Right (002-C-02002R)

(UDI)/Lot: a) (18056099647588) B1096741; b) (18056099647595) B1117260, B1099064; c) (18056099647625) B1117352, B1096743; d) (18056099647632) B1099065 e) (18056099647601) B1117265, f) (18056099647618) B1098803, B1116361; g) 18056099647649) B1200565, B1116364; h) (18056099647656) B1123046,

Product: 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)

(UDI)/Lot: a) (18056099647830) B1108952; b) (18056099647847) B1108955

Product: 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)

(UDI)/Lot: a) (18056099647557) B1098799, B1115575; (18056099647564) B1113628; (18056099647571) B1098800

Product: 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)

(UDI)/Lot: a) (18056099647809) B1096736; b) (18056099647816) B1096738; c) (18056099647823) B1096739

Product: 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)

(UDI)/Lot: a) (18056099647663) B1099060; b) (18056099647670) B1099062; c) (18056099647687) B1099066

Product: 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)

(UDI)/Lot: a) (18056099647762) B1098805; b) (18056099647779) B1102020

Product: 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)

(UDI)/Lot: a) (18056099647786) B1102163; (b (18056099647793) B1106912

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79819

Status: Resolved

Manufacturer: Orthofix, Inc

Manufactured In: United States

Units Affected: 19 products (50; 100; 50; 601; 870; 935; 1302; 1206; 1574; 54; 24; 52; 75; 156; 30; 38; 24; 36; 36)

Agency Last Updated: June 30, 2021

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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