Orthofix, Inc: Medical Device Recall in 2018 - (Recall #: Z-2128-2018)

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:

H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001)

Product Classification:

Class II

Date Initiated: April 6, 2018

Date Posted: June 13, 2018

Recall Number: Z-2128-2018

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: 75

Code Information:

Lot: B1212400, Date of Manufacture: 2017-11-13, Use By: 2022-10-13, (UDI)/Lot: a) (18056099647908) B1096740; b) (18056099647915) B1096733; c) (18056099647939) B1096734; d) (18056099647953) B1096735; e) (18056099647960) B1100226

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