The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2118-2018·Announced 2018-06-13

Orthofix Recalls Rival Reduce Kit Plates Due to Screw Engagement Failure

Orthofix, Inc. is voluntarily recalling 50 units of Rival Reduce Kit Plates 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 where locking screws failed to engage plates during surgery, posing a significant risk of injury.

Plain-English summary

Orthofix, Inc. is conducting a voluntary recall of 50 units of Rival Reduce Kit Plates, sterile, prescription only, Part Number 000-K-012C. The product is labeled with ORTHOFIX S.r.r. Italy. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. The affected units are associated with UDI 18056099648608 and Lot B1107421.

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 and patients should contact Orthofix, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
Manufacturer
Orthofix, Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
50

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: 18056099648608
  • Lot: B1107421

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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