Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System components because locking screws failed to properly engage plates during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a confirmed mechanical defect (screws not engaging plates) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
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 H-Plate spacers, including 12MM, 15MM, 20MM, 25MM, and 30MM sizes, manufactured by Orthofix S.r.r. Italy. The affected units are sterile, prescription-only medical devices.
The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. This mechanical failure could compromise the stability of the orthopedic fixation. The recall covers 75 units 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 devices should contact Orthofix, Inc. for further instructions. The source text does not report any specific injuries or illnesses associated with this defect, but the mechanical failure presents a risk of harm during or after surgical procedures.
The recalled product
- Product
- H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001)
- Manufacturer
- Orthofix, Inc
- Affected units
- 75
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 (8)
- Lot: B1212400
- Date of Manufacture: 2017-11-13
- Use By: 2022-10-13
- (UDI)/Lot: a) (18056099647908) B1096740
- b) (18056099647915) B1096733
- c) (18056099647939) B1096734
- d) (18056099647953) B1096735
- e) (18056099647960) B1100226
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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See all →- HighOrthofix Non-Locking Screws Recalled Due to Failure to Engage Plates
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- SevereOrthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure
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