Z-2126-2018 Class II Terminated
FDA device recall Z-2126-2018 was initiated by Orthofix, Inc on Apr 6, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jun 30, 2021). Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 13, 2018
- Initiation Date
- Apr 6, 2018
- Termination Date
- Jun 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
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 Pattern
U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
Code Information
(UDI)/Lot: a) (18056099647694) B1099067; b) (18056099647700) B1099061; c) (18056099647717) B1099063
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2126-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026