The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2126-2018·Announced 2018-06-13

Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the 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 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 is classified as FDA Class II and involves a structural defect in a medical device (locking screws failing to engage plates) that could lead to significant injury or surgical failure, meeting the criteria for a Severe rating.

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 24 units of CC Plates, Sterile, Rx Only, in Small, Medium, and Large sizes. The products were 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.

The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. This defect could potentially compromise the stability of the fracture fixation during the procedure.

Healthcare providers and facilities that have received these products should stop using them and contact Orthofix, Inc. for further instructions on how to return the devices. Patients who have had these implants placed should consult their healthcare provider if they have concerns about the stability of their fracture fixation.

The recalled product

Product
CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
Manufacturer
Orthofix, Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
24

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 (3)

  • (UDI)/Lot: a) (18056099647694) B1099067
  • b) (18056099647700) B1099061
  • c) (18056099647717) B1099063

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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