medical Class II Updated 2018-06-13

Orthofix, Inc recalls Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on la

Recalled 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)

Hazard / Issue

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.

Issued by

FDA

Affected States: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK

Lot/Code Info: (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,

View official government recall

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