Orthofix Rival Plating System Recalled Due to Screw Engagement Failure
Orthofix is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System because locking screws failed to properly 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 3/5 (High).
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 is classified as FDA Class II, and the source describes a functional defect (screws not engaging) that poses a risk of harm during surgery, but no specific injuries or illnesses are reported in the text.
Plain-English summary
Orthofix, Inc. is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgical procedures.
The affected products include specific Evans Plate spacers in 6MM, 8MM, 10MM, and 12MM sizes, manufactured by Orthofix, Inc. The recall involves 52 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 plating systems should contact Orthofix, Inc. for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); b) 8MM Spacer (022-H-00008); c) 10MM Spacer (002-H-00010); d) 12MM Spacer (002-H-00012)
- Manufacturer
- Orthofix, Inc
- Affected units
- 52
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: B1212604
- Date of Manufacture: 2017-11-15
- Use By: 2022-10-15
- UDI: a) (18056099647724) B1099059
- B1123627
- b) (18056099647731) B1099057
- c) (18056099647748) B1099068
- d (18056099647755) B1099069
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
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure
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- SevereOrthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
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- SevereOrthofix Recalls MTP Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
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