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Recall Observatory FDA recall evidence

Device product

Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)

Z-2125-2018

April 06, 2018

Class II

Product summary

Firm
Orthofix, Inc
Event
Event 79819
Status
Terminated
Classification
Class II
Quantity
54
Official record key
device-enforcement:Z-2125-2018

Official wording

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.

Code information: (UDI)/Lot: a) (18056099647854) B1102026; b) (18056099647878) B1101930; c) (18056099647892) B1098806

Distribution pattern: U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.