The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2128-2018·Announced 2018-06-13

Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System components because locking screws failed to properly engage plates 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a confirmed mechanical defect (screws not engaging plates) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Orthofix, Inc. is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. The recall involves specific H-Plate spacers, including 12MM, 15MM, 20MM, 25MM, and 30MM sizes, manufactured by Orthofix S.r.r. Italy. The affected units are sterile, prescription-only medical devices.

The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. This mechanical failure could compromise the stability of the orthopedic fixation. The recall covers 75 units distributed to consignees in various U.S. states, including New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, the District of Columbia, Nevada, Indiana, California, Michigan, Illinois, Maryland, North Carolina, Ohio, and Oklahoma.

Healthcare providers and patients who have used these specific devices should contact Orthofix, Inc. for further instructions. The source text does not report any specific injuries or illnesses associated with this defect, but the mechanical failure presents a risk of harm during or after surgical procedures.

The recalled product

Product
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)
Manufacturer
Orthofix, Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
75

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 (8)

  • Lot: B1212400
  • Date of Manufacture: 2017-11-13
  • Use By: 2022-10-13
  • (UDI)/Lot: a) (18056099647908) B1096740
  • b) (18056099647915) B1096733
  • c) (18056099647939) B1096734
  • d) (18056099647953) B1096735
  • e) (18056099647960) B1100226

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 →

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