FDA (Devices) recall action 79819
The FDA (Devices) publishes a recall like this one as 20 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 20 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.
Orthofix, Inc. is voluntarily recalling specific MTP plates because locking screws failed to properly engage during surgery.
Orthofix is voluntarily recalling Rival Reduce Fracture and View Plating Systems because locking screws failed to engage plates during surgery.
Orthofix, Inc. is voluntarily recalling specific Non-Locking Screws because they failed to properly engage plates during surgery.
Orthofix, Inc. is voluntarily recalling specific Rival Reduce Fracture Plating and Rival View Plating System box plates because locking screws failed to properly engage during surgery.
Orthofix, Inc. is voluntarily recalling specific non-locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.
Orthofix, Inc. is voluntarily recalling specific non-locking screws used in fracture plating systems because they failed to properly engage plates during surgery.
Orthofix is voluntarily recalling Rival Reduce Fracture Plating and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.
Orthofix is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System because locking screws failed to properly engage plates during surgery.
Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.
Orthofix, Inc. is voluntarily recalling Rival View Kit locking screws that failed to properly engage plates during surgery.
Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.
Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.
Orthofix, Inc. is voluntarily recalling 50 units of Rival Reduce Kit Plates because locking screws failed to properly engage the plates during surgery.
Orthofix is voluntarily recalling Rival Reduce Kit locking screws because they failed to properly engage plates during surgery.
Orthofix is voluntarily recalling 156 Lapidus Plates because locking screws failed to properly engage the plates during surgery.
Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.
Orthofix, Inc. is voluntarily recalling locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they were confirmed to not properly engage plates during surgery.
Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System components because locking screws failed to properly engage plates during surgery.
Orthofix is voluntarily recalling TN Plates because locking screws failed to properly engage the plates during surgery.