The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2135-2018·Announced 2018-06-13

Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

Orthofix is voluntarily recalling Rival Reduce Fracture and View Plating Systems because locking screws failed to 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 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, which aligns with the rubric criteria for 'structural vehicle defect' or significant injury/property-damage reports, warranting a Severe classification.

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 36 units of Y-Plate, Sterile, Rx Only, in Small and Large sizes, manufactured by Orthofix, Inc.

The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. The affected products were distributed to consignees in 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 should stop using the affected devices and contact Orthofix, Inc. for further instructions or a replacement. The specific lot numbers involved are B1102163 and B1106912.

The recalled product

Product
Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
Manufacturer
Orthofix, Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
36

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 (2)

  • (UDI)/Lot: a) (18056099647786) B1102163
  • (b (18056099647793) B1106912

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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