Recall Z-2128-2018— Orthofix, Inc

Name: FDA recall Z-2128-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-06

Class II · Terminated

Class II FDA medical device recall by Orthofix, Inc, initiated 2018-04-06, terminated 2021-06-30. It names one FDA 510(k) clearance: K142135. Product: 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). Reason: 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..

Recalling firm: Orthofix, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-04-06
Terminated: 2021-06-30
Firm location: Lewisville, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K142135 — REDUCE FRACTURE PLATING SYSTEM LINE EXTENSIONIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic·cleared 2014-08-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.