The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2134-2018·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 implant (locking screws failing to engage plates) that compromises the primary function of the device during surgery, meeting the criteria for a Severe rating due to significant injury risk.

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 the T-Plate, Sterile, Rx Only, manufactured by Orthofix, Inc. The affected products are identified by the following UDI/Lot numbers: (18056099647762) B1098805 for the Small size (Part Number 003-B-01001) and (18056099647779) B1102020 for the Large size (Part Number 003-B-02001).

The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. This defect poses a risk to patients who have had these specific devices implanted, as the failure of the screws to engage the plates could compromise the stability of the fracture fixation.

The affected units were distributed to consignees in the following U.S. states and districts: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, and OK. Healthcare providers and patients who have received these specific lots of the Rival plating systems should contact Orthofix, Inc. for further instructions on the recall and potential replacement or removal of the devices.

The recalled product

Product
T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-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) (18056099647762) B1098805
  • b) (18056099647779) B1102020

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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