medical Class II Updated 2018-06-13

Orthofix, Inc recalls Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy o

Recalled 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-20030)

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) (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

View official government recall

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