Orthofix, Inc: Medical Device Recall in 2018 - (Recall #: Z-2120-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 (002-E-20030)

Product Classification:

Class II

Date Initiated: April 6, 2018

Date Posted: June 13, 2018

Recall Number: Z-2120-2018

Event ID: 79819

Reason for Recall:

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.

Status: Terminated

Product Quantity: 870

Code Information:

(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

Distribution Pattern:

U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,

Voluntary or Mandated:

Voluntary: Firm initiated