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)
Enforcement
- Recall Number
- Z-2129-2018
- Event ID
- 79819
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Orthofix, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 13, 2018
- Initiation Date
- April 6, 2018
- Classification Date
- June 7, 2018
- Termination Date
- June 30, 2021
- Address
- 3451 Plano Pkwy, N/A, Lewisville, TX, 75056-9453, United States
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)
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.
(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,
U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
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