Recall Z-2116-2018— Orthofix, Inc
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: 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-011C. 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 recordK-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
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-011C
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.