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Recall Observatory FDA recall evidence

Device product

Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)

Z-2132-2018

April 06, 2018

Class II

Product summary

Firm
Orthofix, Inc
Event
Event 79819
Status
Terminated
Classification
Class II
Quantity
38
Official record key
device-enforcement:Z-2132-2018

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) (18056099647809) B1096736; b) (18056099647816) B1096738; c) (18056099647823) B1096739

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.