Z-2129-2018 Class II Terminated
FDA device recall Z-2129-2018 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: 156.
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
- 156
Product Description
Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e) Small/2MM Step/Left (002-C-01002L); f) Small/2MM Step/Right (002-C-01002R); g) Large/2MM Step/Left (002-C-02002L); h) Large/2MM Step/Right (002-C-02002R)
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) (18056099647588) B1096741; b) (18056099647595) B1117260, B1099064; c) (18056099647625) B1117352, B1096743; d) (18056099647632) B1099065 e) (18056099647601) B1117265, f) (18056099647618) B1098803, B1116361; g) 18056099647649) B1200565, B1116364; h) (18056099647656) B1123046,
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2129-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026