Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: structural-defect
surgical-failure

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 →

Same manufacturer · Orthofix, Inc

See all →

Severe
Orthofix Recalls Non-Locking Screws for Improper Plate Engagement
FDA (Devices) · 2018-06-13
High
Orthofix Non-Locking Screws Recalled Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13
Severe
Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
Severe
Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
Severe
Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13

Same hazard · structural defect