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Terminated

H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001)

FDA Recall Z-2128-2018 · Posted 2018-06-07

Recalling FirmOrthofix, Inc
Recall StatusTerminated
Product CodeHRS
Date Initiated2018-04-06
Date Terminated2021-06-30
Product Quantity75

Reason for Recall

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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