Recall Z-2120-2018— Orthofix, Inc

Name: FDA recall Z-2120-2018
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: K140876. Product: 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). 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

K140876 — VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREWIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic·cleared 2014-07-22

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

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)

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.