Skip to content
Recall Observatory FDA recall evidence

Device product

Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C

Z-2118-2018

April 06, 2018

Class II

Product summary

Firm
Orthofix, Inc
Event
Event 79819
Status
Terminated
Classification
Class II
Quantity
50
Official record key
device-enforcement:Z-2118-2018

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: 18056099648608, Lot: B1107421,

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.