medical Class II Updated 2018-06-13

Orthofix, Inc recalls Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on la

Recalled 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 2.7MM X 32MM (002-E-27032); n) D 2.7MM X 34MM (002-E-27034); o) D 2.7MM X 36MM (002-E-27036); p) D 2.7MM X 38MM (002-E-27038); q) D 2.7MM X 40MM (002-E-27040)

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) (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
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