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

Is my product affected?

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

• UPC 18056099648608

Check against the official notice below — it lists the full affected range.

What happened

Orthofix, Inc. is voluntarily recalling the Rival Reduce Fracture Plating System and Rival View Plating System (Part Number 000-K-012C) due to a confirmed defect in which locking screws do not properly engage the plates during surgery. The affected product is a sterile, prescription-only medical device manufactured by Orthofix S.r.l. in Italy, with 50 units distributed across multiple U.S. states including California, Texas, Florida, and others.

The recall affects devices with UDI 18056099648608 and Lot B1107421. The source document does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK, Quantity: 50 Lot/code info: UDI: 18056099648608, Lot: B1107421,

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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-011C2018-04-06
• 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-009C2018-04-06
• 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 2018-04-06
• 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) 2018-04-06
• 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)2018-04-06

All FDA (Device enforcement) recalls