The Recall Desk
SevereFDA (Devices)·Z-2131-2018·Announced 2018-06-13

Orthofix Recalls MTP Plates Due to Screw Engagement Failure

Orthofix, Inc. is voluntarily recalling specific MTP plates because locking screws failed to properly engage during surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device where components failed to engage during surgery, posing a significant risk of injury or surgical failure, which aligns with the 'Severe' criteria for significant injury reports or structural defects.

Plain-English summary

Orthofix, Inc. is conducting a voluntary recall of the MTP Plate, Sterile, Rx Only, manufactured by ORTHOFIX S.r.r. Italy. The recall covers Small, Medium, and Large sizes with specific part numbers and lot codes.

The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. This defect affects the Rival Reduce Fracture Plating System and Rival View Plating System.

The affected products were distributed to consignees in New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, Washington D.C., Nevada, Indiana, California, Michigan, Illinois, Maryland, North Carolina, Ohio, and Oklahoma. Healthcare providers should stop using the affected units and contact Orthofix, Inc. for further instructions.

The recalled product

Product
MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)
Manufacturer
Orthofix, Inc
Category
Medical Device — Orthopedic Implant
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • (UDI)/Lot: a) (18056099647557) B1098799
  • B1115575
  • (18056099647564) B1113628
  • (18056099647571) B1098800

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 20 recalled by Orthofix, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

Related recalls

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Same hazard · structural defect

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