Recall Z-2129-2018 ยท HRS Plate, Fixation, Bone
Orthofix, Inc
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
| Date | Jun 7, 2018 (initiated Apr 6, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier. |
| Quantity | 156 |
| Distribution | U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140876 | VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic, Jul 22, 2014 |