Orthofix Recalls Rival 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.
What this means for you
Illness, injury, or structural failure has been reported. 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 the Rival Reduce Fracture Plating System and Rival View Plating System. The recall involves specific L-Plate components, including sterile, prescription-only plates manufactured by Orthofix, Inc. The affected products are identified by specific part numbers for left and right configurations and associated UDI/Lot codes.
The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. This mechanical failure poses a risk to patient safety during orthopedic procedures. The agency has classified this recall as Class II.
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. Healthcare providers and patients who have used these specific products should contact Orthofix, Inc. for further instructions on replacement or return.
The recalled product
- Product
- L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
- Manufacturer
- Orthofix, Inc
- Affected units
- 30
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) (18056099647830) B1108952
- b) (18056099647847) B1108955
Distribution
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 →Related recalls
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